regulatory affairs analyst

Acino

<div>Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide. 
Main duties 
<ul>
<li>Completes low and medium complexity regulatory assignments and ensures timely execution of tasks.</li>
<li>Plans, prepares, compiles, and submits high-quality regulatory applications for Egypt in compliance with applicable requirements, and prepares electronic submission files using document management tools such as DocuBridge.</li>
<li>Tracks the status of applications under regulatory review, provides updates to internal and external stakeholders, and maintains regulatory documentation and internal databases such as ARCERA.</li>
<li>Revises and approves artwork for product packaging materials in internal systems according to applicable guidelines and ensures adherence to regulatory compliance and standard operating procedures.</li>
<li>Schedules and organizes meetings with internal and external stakeholders, prepares materials for these meetings, and actively participates in discussions.</li>
<li>Communicates regulatory requirements to other departments, provides regulatory support to project teams and stakeholders, and attends internal trainings in due time.</li>
<li>Forwards all received Product Quality Complaints, Adverse Events, and Medical Information Requests to the relevant teams in Quality Assurance, Pharmacovigilance, and Medical Affairs.</li>
<li>Ensures compliance with applicable legislation, maintains internal regulatory information systems, and supports continuous improvement of regulatory processes.</li>
</ul>
Job Requirements
<ul>
<li>Bachelor&rsquo;s degree in pharmacy, chemistry, biology, or another life science.</li>
<li>Minimum of two years&rsquo; experience in Regulatory Affairs within a relevant discipline; prior experience in a similar role is considered an advantage.</li>
<li>Business English at least at intermediate level</li>
<li>Strong understanding of regulatory requirements, processes, procedures, and submission pathways.</li>
<li>In-depth knowledge of regulatory life cycle management for pharmaceutical products.</li>
<li>Proven ability to collaborate effectively within cross-functional project teams.</li>
<li>Demonstrates alignment with ARCERA principles and organizational values in all actions and decisions.</li>
<li>Exhibits strong verbal and written communication skills, with a high level of accuracy and attention to detail.</li>
<li>Possesses excellent interpersonal skills, with the ability to collaborate effectively across diverse functions, cultures, and organizational levels, including external business partners.</li>
<li>Applies sound project management capabilities to plan, organize, and deliver tasks efficiently.</li>
<li>Shows adaptability and a proactive mindset by embracing challenging assignments and pursuing opportunities that foster professional growth and capability development.</li></ul> 


This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!</div>

Regulatory Affairs Specialist

State of Washington

<div><div><div><h2 class="jobSectionHeader">Description</h2></div>
<div>Persons requiring reasonable accommodation in the application process or requiring information in an alternative format may contact the recruitment team at HREmployment@atg.wa.gov. Those with a hearing impairment in need of accommodation are encouraged to contact the Washington Relay Service at 1-800-676-3777 or www.washingtonrelay.com.
Position and Salary 
The Attorney General&rsquo;s Office is recruiting for a permanent full time Regulatory Analyst 2 in the Public Counsel Unit of the Consumer Protection Division. This position is located in Seattle, Washington, and is represented by the Washington Federation of State Employees (WFSE). 
 
Regulatory Analyst 2 Salary range 60: $69,744 - $93,804 
The base pay offered will take into account internal equity and may vary depending on the preferred candidate&rsquo;s job-related knowledge, skills, and experience.
The following stipends may apply based on position requirements:<ul><li>
Incumbents assigned to our Seattle office location receive an additional 5% King County Location Pay stipend.</li><li>
Incumbents assigned to a position designated as requiring dual language skills will receive a 5% Dual Language Requirement Pay stipend.</li></ul>
The AGO provides a workplace that is understanding of work-life balance and promotes advancement by offering a wide variety of professional development and growth opportunities. 
Excellent benefits 
 
Washington State offers one of the most competitive benefits packages in the nation, including Medical/Dental/Vision for employees &amp; dependent(s); Vacation, Sick, and Other Leave; 11 Paid Holidays per year; Public Employees Retirement System (PERS) plans; and Life Insurance. Beyond these traditional benefits, we offer Dependent Care Assistance, Flexible Spending Accounts, Public Service Loan Forgiveness, Tuition Waiver, Deferred Compensation, Employee Recognition Leave, and more. With the goal of employee health and wellness, we also offer:<ul><li>
Flexible schedules and part-time/hybrid telework options;</li><li>
A Wellness Program, an Infants in the Workplace Program, and the Employee Assistance Program, which provides counseling, webinar, and other cost-free support resources;</li><li>
Numerous employee-driven affinity groups to foster community and connection, including Bereavement, Elder Care, Parenting, POC, LGBTQ+, Veterans and more. The AGO is a place to belong and make a difference!</li></ul> 
About Public Counsel
The Public Counsel Unit of the Washington Attorney General&rsquo;s Office represents customers of state-regulated, investor-owned utility companies in matters before the Washington Utilities and Transportation Commission (WUTC), state courts, and the legislature. Our guiding mission is to ensure that regulated utilities charge fair and reasonable rates and provide safe and reliable service. 
Duties and Essential Functions of a Regulatory Analyst 2 
Regulatory Analyst 2 plans and performs economic, financial, or policy research and analysis to formulate and support the Units&rsquo; position on major utility rate cases and other significant proceedings as an advocate for the citizens of Washington state. This position provides technical assistance on regulatory matters and will help formulate recommendations, as well as communicate the Unit&rsquo;s position to the Deputy Attorney General, Division Chief, assistant attorneys general, UTC Staff and Commissioners, and other government agencies or interested parties, as appropriate. This position may direct the work of professional staff and/or regulatory analyst staff on a project basis. 
Qualifications
A Bachelor&rsquo;s degree involving major study in economics, accounting, business or public administration, finance, social sciences, engineering, law or related field and three (3) years of professional research or analysis experience with an institution engaged primarily in regulatory matters; or two years as a Regulatory Analyst 1 or equivalent.<ul><li>
Research analysis experience in other capacities may be accepted.</li><li>
An advanced degree in one of the fields listed above will substitute for one year of the desired experience.</li></ul>
Skills and Abilities<ul><li>
Ability to perform complex research and analysis of rates, operations and service of regulated utility companies</li><li>
Ability to collaborate with attorneys, other analysts, staff and external experts</li><li>
Clear, concise oral and written communication</li><li>
Ability to maintain multiple competing case assignments</li></ul> 
About the Washington State Office of the Attorney General 
The Attorney General&rsquo;s Office (AGO) touches the lives of every resident in this state. We serve more than 230 state agencies, boards, commissions, colleges and universities, as well as the Legislature and the Governor. The Office is comprised of nearly 700 attorneys and 800 professional staff, all working together to deliver the highest quality professional legal services to Washington state officials, agencies, and entities. This includes: 
<ul><li>
Economic justice and consumer protections (safeguarding consumers, protecting youth, seniors, and other vulnerable populations)</li><li>
Social justice and civil rights (addressing discrimination, environmental protection, and veteran and military resources)</li><li>
Criminal justice and public safety (investigative and prosecutorial support, financial crimes)</li><li>
And much more!</li></ul>
Our agency also has national reach, representing the State of Washington before the Supreme Court, the Court of Appeals and trial courts in all cases that involve the state&rsquo;s interest. If you want to make a difference, we may be the perfect fit for you! Learn more about the AGO here. 
Commitment to Diversity 
Diversity is critical to the success of the mission of the AGO. This means recognizing, respecting, and appreciating all cultures and backgrounds- and fostering the inclusion of differences between people. Appreciating, valuing and implementing principles of diversity permits AGO employees to achieve their fullest potential in an inclusive, respectful environment. 
 
One recent measure of the AGO's commitment to diversity can be found in its nomination for Rainbow Alliance and Inclusion Network's &quot;Outstanding Agency Award&quot; in 2019. Our commitment to employee wellness is reflected in earning the 2024 Zo8 Washington Wellness Award. 
Application Instructions
In addition to completing the online application, applicants must attach the following documents to their profile in order to be considered for this position:<ul><li>
A letter of interest, describing your specific qualifications for the position;</li><li>
A current resume detailing experience and education.</li></ul>
Read the Following Information Completely:<ul><li>
Carefully review your application for accuracy, spelling and grammar before submitting.</li><li>
You may not reapply to this posting for 30 days.</li><li>
The initial screening of applications will be solely based on the contents and completeness of the &ldquo;work experience&rdquo; and &ldquo;education&rdquo; sections of your application in www.careers.wa.gov, completeness of the application material submitted, and responses to the supplemental questionnaire.</li><li>
A resume will not substitute for completing the &ldquo;work experience&rdquo; section of the application.</li><li>
All information may be verified and documentation may be required.</li><li>
The Washington State Office of the Attorney General does not use the E-Verify system; therefore, we are not eligible to extend STEM Optional Practical Training (OPT). For more information, please visit www.uscis.gov.</li></ul> 
Equal Employment Opportunity and Accommodations Requests
Honoring diversity, equity and inclusion means that as an agency, and as individuals, we are committed to ensuring that all employees and volunteers enjoy a respectful, safe and supportive working environment. Only by fostering the inclusion of people from all backgrounds, cultures and attributes, can AGO employees and volunteers achieve their fullest potential and best advance the goals and mission of the AGO.
The AGO is an equal opportunity employer and does not discriminate on the basis of race, creed, color, national origin, sex, marital status, sexual orientation/gender identity, age, disability, honorably discharged veteran or military status, retaliation or the use of a trained dog guide or service animal by a person with a disability. Persons requiring reasonable accommodation in the application process or requiring information in an alternative format may contact the recruitment team at HREmployment@atg.wa.gov. Those with a hearing impairment in need of accommodation are encouraged to contact the Washington Relay Service at 1-800-676-3777 or www.washingtonrelay.com.
For questions regarding this recruitment or assistance with the application process, please contact the recruitment team at HREmployment@atg.wa.gov. If you are having technical difficulties creating, accessing or completing your application, please call NEOGOV toll-free at (855) 524-5627 or support@neogov.com.</div></div></div>

Regulatory Analyst 2, Public Counsel Unit of the Consumer Protection Division, Seattle

Boston Scientific

<div>Additional Location(s): US-MN-Arden Hills 
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance 
At Boston Scientific, we&rsquo;ll give you the opportunity to harness all that&rsquo;s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we&rsquo;ll help you in advancing your skills and career. Here, you&rsquo;ll be supported in progressing &ndash; whatever your ambitions. 
<div><div><div><div><div><div>About the role: 
Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. 
The Regulatory Affairs Fellow supports the review and approval of advertising, promotional, sales support, and training materials for Electrophysiology medical devices. This role applies a risk-based regulatory mindset to ensure materials are accurate, balanced, appropriately substantiated, and aligned with applicable regulations and internal procedures. The Fellow partners cross-functionally to enable compliant, effective communication that supports business objectives while protecting patients and the company. 
Work model, sponsorship:
At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. 
Your responsibilities will include:<ul><li>Review and provide regulatory feedback on advertising and promotional materials, including print, digital, web, email, social media, video, webinars, sales aids, and training or education materials.</li><li>Assess proposed product claims for alignment with cleared or approved indications.</li><li>Evaluate content for appropriate context, fair balance, and compliant presentation of benefits, risks, limitations, and required disclosures.</li><li>Recommend clear, actionable edits to strengthen compliance while supporting commercial objectives.</li><li>Confirm that promotional claims are supported by appropriate clinical, performance, or bench evidence and are referenced correctly.</li><li>Escalate high-risk or novel claims, comparative statements, testimonials, and graphics or data visualizations for cross-functional review.</li><li>Follow applicable SOPs and work instructions for promotional material review and approval; ensure review records are complete, appropriately documented, and stored.</li><li>Contribute to continuous improvement by identifying recurring issues, proposing mitigations, and supporting updates to templates and job aids.</li><li>Partner with Marketing and content creators early in the development process to guide compliant concepts and messaging.</li><li>Collaborate with Medical, Clinical, Legal, Quality, Compliance, and Product teams to resolve questions related to evidence, labeling alignment, and risk communications.</li><li>Participate in cross-functional promotional review forums and meetings and clearly document and communicate decisions.</li><li>Assist with developing and delivering training materials, FAQs, and checklists for Marketing and other stakeholders as assigned.</li><li>Represent Regulatory when promotional and advertising materials are reviewed during FDA and Notified Body audits.</li></ul> 
Required qualifications:<ul><li>Bachelor&rsquo;s degree in life sciences, engineering, pharmacy, public health, communications, or a related discipline.</li><li>Minimum of 10 years' experience in Regulatory Affairs or related compliance experience within the medical device industry and experience directly reviewing advertising, promotional, sales, and training materials for medical devices.</li><li>Demonstrated working knowledge of FDA and EU regulatory frameworks impacting medical device promotion and communications.</li><li>Experience evaluating product claims for alignment with cleared or approved indications for use.</li><li>Experience assessing clinical, performance, and bench data to substantiate promotional claims.</li><li>Experience applying regulatory requirements related to fair balance, risk communication, and required disclosures within promotional materials.</li><li>Experience participating in cross-functional promotional review processes or committees.</li><li>Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.</li></ul> 
Preferred qualifications:<ul><li>Advanced degree in life sciences, engineering, pharmacy, public health, communications, or a related discipline.</li><li>Strong written and verbal communication skills with the ability to translate regulatory requirements into clear, actionable guidance for nonregulatory audiences.</li><li>Demonstrated ability to influence without authority and collaborate effectively within cross-functional teams.</li><li>Strong writing, editing, and critical-thinking skills with attention to detail.</li><li>Organizational skills with an audit-ready mindset and documentation discipline.</li><li>Learning agility and a continuous improvement orientation.</li><li>Pragmatic problem-solving skills and a coaching mindset.</li></ul> 
#LI-Hybrid</div></div></div></div></div></div> 
Requisition ID: 625013
Minimum Salary: $125800
Maximum Salary: $239000 
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) &ndash; see www.bscbenefitsconnect.com&mdash;will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. 
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). 
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). 
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. 
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn. 
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. 
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company&rsquo;s policies or protocols change with regard to COVID-19 vaccination.</div>

Regulatory Affairs Fellow - Ad Promo

JPMorganChase

<div>JOB DESCRIPTION 
JPMorgan Chase &amp; Co. (NYSE: JPM) is a leading global financial services firm with operations worldwide. The firm is a leader in investment banking, financial services for consumers and small business, commercial banking, financial transaction processing, and asset management. A component of the Dow Jones Industrial Average, JPMorgan Chase &amp; Co. serves millions of consumers in the United States and many of the world&rsquo;s most prominent corporate, institutional and government clients under its J.P. Morgan and Chase brands. Information about JPMorgan Chase &amp; Co. is available at www.jpmorganchase.com.
As a Regulatory Reporting Analyst within the Asia Banking Operations team, you will be responsible for delivering the agenda across the Asia Banking Ops regulatory landscape. You will document and deliver transactional regulatory compliance requirements for APAC, build out the control framework, and ensure sufficient internal controls and procedures are in place to minimize risk. You will work on change management practices for regulatory changes, manage evolving demands, and partner with local and regional key stakeholders to ensure accuracy, completeness, and timeliness of regulatory reports. 
Job Responsibilities:<ul>
<li>Deliver the agenda across the Asia Banking Ops regulatory landscape.</li>
<li>Document and deliver transactional regulatory compliance requirements for APAC.</li>
<li>Build out the control framework and ensure sufficient internal controls to minimize risk.</li>
<li>Exhibit knowledge and understanding of the regulatory environment and its implications.</li>
<li>Work on change management practices for regulatory changes and manage evolving demands.</li>
<li>Keep abreast of regulatory changes and manage evolving demands.</li>
<li>Collaborate with ops on regulatory reporting to ensure accuracy, completeness, and timeliness.</li>
<li>Implement tactical controls and drive automation and improvement opportunities.</li>
<li>Deliver Asia Banking Ops regulatory-related projects.</li>
<li>Partner with local and regional key stakeholders on regulatory requirements.</li>
<li>Ensure accuracy, completeness, and timeliness of regulatory reports.</li></ul>
Required qualifications, skills and capabilities:<ul>
<li>A deep background in banking products and a strong understanding of Asia markets and the regulatory environment
</li><li>Willingness to take ownership and accountability to deliver business goals &ndash; execution to achieve specific desired results
</li><li>Proven ability to use appropriate methods and a flexible interpersonal style to partner with local, regional and global teams
</li><li>Proven ability to identify opportunities and promptly initiate action and escalate potential risks to minimize loss</li>
<li>Strong commitment to providing high standards of controls and compliance</li>
<li>Adaptability in maintaining standards and adjusting effectively to operate within new work structures, processes or requirements</li>
<li>Ability to effectively address and manage conflicts</li>
<li>Ability to communicate pro-actively and openly with internal and external business partners &ndash; to executive level</li>
<li>Proven ability to implement and manage change across direct units as well as remote units.</li></ul>
ABOUT US<div> 
JPMorganChase, one of the oldest financial institutions, offers innovative financial solutions to millions of consumers, small businesses and many of the world&rsquo;s most prominent corporate, institutional and government clients under the J.P. Morgan and Chase brands. Our history spans over 200 years and today we are a leader in investment banking, consumer and small business banking, commercial banking, financial transaction processing and asset management. 
 
We recognize that our people are our strength and the diverse talents they bring to our global workforce are directly linked to our success. We are an equal opportunity employer and place a high value on diversity and inclusion at our company. We do not discriminate on the basis of any protected attribute, including race, religion, color, national origin, gender, sexual orientation, gender identity, gender expression, age, marital or veteran status, pregnancy or disability, or any other basis protected under applicable law. We also make reasonable accommodations for applicants&rsquo; and employees&rsquo; religious practices and beliefs, as well as mental health or physical disability needs. Visit our FAQs for more information about requesting an accommodation.</div> 
 
 
ABOUT THE TEAM 
 
J.P. Morgan&rsquo;s Commercial &amp; Investment Bank is a global leader across banking, markets, securities services and payments. Corporations, governments and institutions throughout the world entrust us with their business in more than 100 countries. The Commercial &amp; Investment Bank provides strategic advice, raises capital, manages risk and extends liquidity in markets around the world.</div>

Regulatory Reporting Analyst

Minapharm Pharmaceuticals

<div>
 
 
 
 
 About Minapharm:
 
 
 
 
 
 Minapharm Pharmaceuticals is a leading pharmaceutical company in Egypt and the Middle East and the largest end-to-end manufacturer of biological therapies in MEA with over 20 years of experience in cellular and bioprocess engineering.
 
 
 
 
 
 Headquartered in Cairo, Minapharm commercializes over 100 life-saving and life-enhancing products ranging from small molecules to complex bioengineered proteins and viral vectors, with an impressive immunotherapy pipeline.
 
 
 
 
 
 Together with its wholly-owned Berlin-based subsidiary, ProBioGen AG - a world-leading CDMO; Minapharm has established an integrated business model making it the only gene-to-market company in the region.
 
 
 
 
 
 Consolidating its international platform of intelligent biopharmaceutical technologies with the longstanding process development and manufacturing expertise in the MEA, Minapharm, together with ProBioGen, have incorporated MiGenTra GmbH headquartered in Berlin and manufacturing in Cairo, to enhance the accessibility to critical healthcare transforming medicines through product development and commercialization of Biosimilar mABs, Cell, and Gene Therapies and vaccines, at affordable prices in Egypt, and MEA.
 
 
 
 
 
 Minapharm Group of Pharmaceutical Companies employ a collective workforce of more than 1400 individuals &amp; continue to expand their workforce with Talented Human Capital
 
 
 
 
 
 
 
 
 Our Core Values:
 
 
 
 
 
 &middot; Diversity &amp; Respect
 
 
 &middot; Integrity &amp; Accountability
 
 
 &middot; Collaboration
 
 
 &middot; Leadership &amp; Empowerment
 
 
 &middot; Innovation &amp; Continuous Learning
 
 
 
 
 
 
 Job Mission :
 
 
 
 Successful job Holder will handle all related new registration/re-registration/variation files of Minapharm/MiGenTra products, ensuring compliance with Egyptian Drug Authority (EDA) guidelines to secure marketing authorizations. Key missions include preparing and submitting registration dossiers &amp; handling renewals and variations.
 
 
 
 
 
 
 Duties &amp; Responsibilities
 
 :
 
 
 Regulatory Affairs - Manufacturing Sector
 
 
 &bull; Plan EDA Visits and communicate with EDA inspector(S).
 
 
 &bull; Ensure compliance with regulations set by EDA.
 
 
 &bull; Prepare and submit all documents and reports requested by the EDA.
 
 
 &bull; Prepare requirement to be ready on time; from QC Department in the Preparation of COAs and reference standards needed to be submitted with finished products samples to center lab NODCAR(&amp;or) Bio - inn
 
 
 &bull; Follow with validation department the submitting of the first three batches for any newly registered product.
 
 
 &bull; Follow Raw Materials upcoming RMs and their documents to facilitate EDA release process.
 
 
 &bull; Archive all the registration documents, EDA reports, samples &amp; COAs for products submitted to NODCAR (&amp;/OR) Bio-Inn.
 
 
 &bull; Follow all NODCAR (&amp;/OR) Bio-Inn requirements for samples submitted to Central lab (EDA)
 
 
 &bull; Handle EDA audits.
 
 
 &bull; Prepare a complete file for each product to contain all documents sent by Registration department
 
 
 &bull; Perform any additional tasks as requested and review Master Files, Drawings, Files related to EDA requirements.
 
 
 
 
 
 
 Qualifications (Educational Background &amp; Preferred work Experience)
 
 :
 
 
 -Not less than 6-9 years in relevant experience.
 
 
 -Education Background : Bachelor&rsquo;s degree in Pharmaceutical sciences is a must.
 
 
 -Training: Training workshops held by EDA or external parties dealing with new/existing law or guidelines related to registration in Egypt.
 
 
 
 
 
 -
 
 Functional / Technical Competencies
 
 : Strong Expertise in the following:
 
 
 &bull;Guidelines of registration process.
 
 
 &bull;Inspection/licensing procedures/ different registration ministerial decree/procedures of different registration submission (stability/pharmacology/naming/variation)
 
 
 
 
 
 -
 
 Behavioral Competencies
 
 :
 
 
 &bull; Business Acumen
 
 
 &bull;Good Communication Skills
 
 
 &bull; Previous proven previous close interaction with Egyptian Drug Authority (EDA)
 
 
 
 
 
 
 Additional Skills:
 
 
 
 &bull; Computer Skills Literacy (familiar with word/excel/PP).
 
</div>

Regulatory Affairs Expert

Covenant HealthCare

<div>Overview:

The Peer Review Data Analyst/Regulatory Affairs Specialist is responsible for applying quality performance metrics and assessing provider performance identifying opportunities for improvement to increase provider knowledge, performance, and competence in relation to privileges granted to positively affect patient outcomes. Determines strategic objectives for the Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Practice Evaluation (OPPE) processes based upon clinical practice needs assessments, Peer Review results, and Quality Initiatives. Coordinates, directs, and analyzes FPPE and OPPE operations and data. Performs monthly Peer Review assessment of hospital wide medical staff complications and works with Peer Review Specialist MSQI to assess next steps of action. Serves as lead in data analysis and reporting of Medical Staff statistics and key performance indicators utilizing the MD Staff/Stat software system. 
Demonstrates excellent customer service performance in that his/her attitude and actions are at all times consistent with the standards contained in the Vision, Mission and Values of Covenant HealthCare and the commitment to Extraordinary Care for Every Generation.
Responsibilities:

FPPE/OPPE Management 
<ul><li>
Coordinates the development of the OPPE universal and department specific measures and other focus reviews as assigned.</li><li>
Directs the Focused Professional Practice Evaluation (FPPE) which involves time-limited monitoring of a provider's practice performance:</li><li><ul><li>
when a provider is initially granted practice privileges;</li><li>
when new privileges are requested for an already privileged provider;</li><li>
when performance non-conformance involving a privileged provider are identified.</li></ul></li><li>
Coordinates FPPE/OPPE reviews with the Medical Staff appointed physician leaders. Ensures timely completion and evaluation of all FPPE and OPPE evaluations per ACHC standards and Medical Staff Bylaws (minimum three performance assessments every two (2) years for every privileged provider on the Covenant Medical Staff).</li><li>
Assists in analyzing the FPPE/OPPE performance measure data and generates reports for physician leader's review.</li><li>
Composes correspondence letters to physicians and other providers as it pertains to FPPE/OPPE program results.</li><li>
Participates in quality assessment and improvement activities, identifies opportunities to improve services, makes recommendations, and implements actions as appropriate and consistent with the goals of the organization.</li><li>
Initiates the monitoring of professional performance as an ongoing process:</li><li><ul><li>
as part of the effort to monitor professional competency;</li><li>
to identify areas for possible performance improvement by individual practitioners; and</li><li>
to use objective data in decisions regarding continuance of practice privileges.</li></ul></li><li>
Influences Medical Staff Leadership by identifying outliers within their respective department and facilitates &quot;next steps&quot; to evaluate or drive improvement in individual provider performance, ie: Further retrospective case review, FPPE, Performance Improvement Plan, additional education, Prospective monitoring, etc.</li><li>
Create, revise, or maintain policies and protocols addressing identified variations, including medical staff determination of validity, written explanation of findings, and, if appropriate, an action plan to include improvement strategies, the need for further training or proctoring, or amendment to privileges to help ensure positive patient outcomes.</li><li>
Enter and manage performance and peer review data within electronic credentialing and privileging systems.</li><li>
Develops and improves ASM/MD Stat software system for FPPE/OPPE Provider Report Cards with skill utilizing MD Staff for special reports as requested.</li></ul> 
Proctor Compliance<ul><li>
Monitors required compliance for provider proctor supervision and completion.</li><li>
Provides follow-up on completion of required proctoring assignments, assessment for criteria met for providers to ensure completion and then assignment to FPPE.</li></ul> 
Data Analysis<ul><li>
Assess Peer Review and Professional Practice Evaluation Program by identifying clinical competence thresholds, opportunities, and processes to achieve improvement, while working with medical staff leaders to develop strategies to enhance clinician performance.</li><li>
Utilizes feedback from Medical Staff leaders and team members, Department Chairs, Section Leaders, and other stakeholders to develop key performance indicators (KPI) and monitor appropriate progress towards those KPIs.</li><li>
Assures the confidentiality, protected status, and integrity of all aspects of Peer Review and Professional Practice Evaluation programs and provides special or routine reports to demonstrate individual or systemic successes or deviations through evaluation tools.</li></ul> 
Complication Review 
<ul><li>
Review monthly Complications report for possible critical actionable items.</li><li>
Utilizing Complication report, assess complications for all medical staff areas analyzing and comparing them to associated criteria to determine any next steps of review and action.</li><li>
Refer to MSQI those complications requiring medical staff leadership critical assessment and management by MSQI Committee with possible referral to Medical Executive Committee.</li><li>
Collaborates with Medical Staff leaders minimally every two (2) years to determine appropriate complication review criteria.</li></ul> 
Cross Departmental 
<ul><li>
Assist in administrative support and provide resources needed for the medical staff to enable them to fulfill their duties and obligations as defined by federal regulatory agencies, bylaws and rules and regulations.</li><li>
Participates in department and hospital programs for quality assessment and improvement, identifies opportunities for improvement, makes recommendations, and implements actions that are consistent with the goals of the organization as requested.</li><li>
Provides support to the Manager of Medical Staff Services, Chief Medical Officer and Chief of Staff by preparing and presenting ad hoc reports related to provider performance and evaluation.</li><li>
Ensures continuous compliance with regulatory bodies such as CMS, ACHC and others for applicable regulatory requirements, including consulting with regulatory bodies to demonstrate compliance.</li><li>
Communicate successes and deviations to practitioners and their department and medical staff leaders.</li><li>
Represent medical staff services on assigned committees as requested.</li><li>
In the absence of MSQI Peer Review Specialist, facilitate Peer Review Meetings (MSQI, SDMC, etc.) including preparation, attendance, feedback communication, transcription of minutes, and all other aspects of meetings.</li><li>
As required, possess the ability to create policies and procedures appropriate to duties being performed.</li><li>
Actively participates in meetings, as needed.</li><li>
Provides status updates on work to leadership.</li><li>
Performs other duties as assigned.</li></ul>
Qualifications:

EDUCATION/EXPERIENCE<ul><li>
Bachelor's degree required.</li><li>
Must have and maintain a current Registered Nurse license in the State of Michigan.</li><li>
Three (3) years' experience in acute care hospital setting required.</li><li>
Experience with the utilization of an electronic medical record (EMR) for research and analyzing patient records to complete monthly complication evaluation, review and direction in relation to evaluation criteria; EPIC EMR; and patient safety &amp; quality preferred.</li></ul> 
KNOWLEDGE, SKILLS AND ABILITIES<ul><li>
Knowledge of accreditation standards and State and Federal requirements.</li><li>
Familiarity with hospital accreditation requirements in addition to Federal and State compliance standards.</li><li>
Strong medical terminology and pharmacology knowledge</li><li>
Strong skills in use of ASM / MD Stat database software for collection, distribution and reporting out of FPPE/OPPE provider performance.</li><li>
Strong skills in Microsoft Excel, Word, PowerPoint and Adobe.</li><li>
Excellent communication skills to effectively convey project goals, objectives and expectations to team members, stakeholders, team members, and senior management.</li><li>
Ability to manage time effectively and ensure that projects are completed on time or project timelines adjusted to compensate for challenging projects or other circumstances.</li><li>
Demonstration of leadership skills with ability to interact and direct all levels of individuals.</li><li>
Ability to work and communicate effectively with various levels of management personnel, physicians, universities, nurses, other IRBs, regulatory inspectors, etc.</li><li>
Advanced skills and experience in leading and facilitating groups, decision-making and conflict resolution.</li><li>
Ability to independently make sound decisions and direct workflow.</li><li>
Excellent time management and organizational skills with attention to detail.</li><li>
Excellent analytical, critical thinking and problem-solving skills.</li><li>
Demonstrates ability to maintain information in a confidential manner.</li></ul>
WORKING CONDITIONS/PHYSICAL DEMANDS<ul><li>
Ability to maintain punctual attendance consistent with the ADA, FMLA, and other federal, state, and local standards.</li><li>
Frequent standing, walking, sitting, handling, feeling, talking, hearing and near vision.</li><li>
Occasional lifting 0-10 lbs.</li><li>
Occasional reclining, lifting, carrying, pushing, pulling, climbing, balancing, stooping, kneeling, crouching, squatting, crawling, twisting, reaching, far vision and depth perception.</li></ul></div>

RN PEER REVIEW DATA ANALYST / REGULATORY AFFAIRS SPECIALIST

Citi

<div>Citi&rsquo;s Risk Modeling Solutions department is responsible for the development, delivery, and monitoring of all credit risk models across Citi&rsquo;s consumer lending portfolios globally. These models span two core activities; granting and managing credit to individual customers and delivering loss forecasts for stress testing (ex. CCAR), loan loss reserving (ex. CECL), and business planning. The Model/Anlys/Valid Analyst II - C10 position sits within the Global Mortgage Regulatory Model Development team and specifically part of the Modeling Analytics team and is responsible for developing champion/benchmark risk models for Citi's international and U.S. secured portfolios for CCAR, CECL, ICAAP, IFRS9, climate risk, and other regulatory/internal usage. 
Responsibilities:
Position responsibilities include but not limited to the following activities:<ul><li>
Participate in building champion/benchmark models for CCAR, CECL, IFRS9, climate risk, and other regulatory/internal purposes for Citi's international and U.S. secured portfolios.</li><li>
Under manager's guidance, perform data cleansing and analysis, identify static and dynamic portfolio drivers and macroeconomic drivers for portfolio risk performances, build PD/EAD/LGD models and conducting statistical analysis and backtests, perform forecast sensitivity analysis and model robustness tests, and provide model implementation and validation support.</li><li>
Create Model Development Document for validation and supporting Annual Model Reviews and Ongoing Performance Assessment of implemented models.</li><li>
Participate in model revalidation, model change and related documentation and validation support efforts.</li><li>
Ensure timely completion of assigned projects with high quality.</li><li>
Work closely with cross functional teams, including country/region&rsquo;s business stakeholders, model validation and governance teams, and model implementation team</li><li>
Prepare responses/presentations to regulatory agencies on all CCAR/CECL/IFRS9/Climate models built</li></ul>
Qualifications:<ul><li>
2+ years of experience in performing quantitative analysis, statistical modeling, loss forecasting, loan loss reserve modeling, or econometric modeling and in-depth knowledge on the use of statistical models to solve business problems (years of experience in Master or PhD programs of Statistics, Economics, Finance, Biomedical Engineering or other highly quantitative discipline counts).</li><li>
Past experience of climate risk stress testing or catastrophe modeling preferred</li><li>
Experience of end-to-end credit risk modeling highly preferred</li><li>
Experience of CCAR and CECL preferred</li><li>
Strong programming (SAS, SQL, Python, R, etc.) and quantitative analytics (regression, time series, decision tree, linear/nonlinear optimization etc.) skills preferred</li><li>
Strong communication skills required to translate model design, specification and performance details to technical and non-technical audiences.</li></ul>
Skillset:<ul><li>
Quantitative Analysis</li><li>
Statistical Modeling</li><li>
Loss forecasting/Loan Loss Reserve Modeling/Econometric Modeling</li><li>
Climate Risk Stress Testing or Catastrophe Modeling</li><li>
Credit Risk Modeling</li><li>
CCAR/CECL Regulations</li><li>
SAS, SQL, Python, R</li></ul>
Education:<ul><li>
Master&rsquo;s/University degree or equivalent experience in Economics, Mathematics, Statistics, Finance of other quantitative discipline</li><li>
PhD degree in Statistics, Economics, Finance, Biomedical Engineering or other quantitative discipline preferred</li></ul>
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Job Family Group:
Risk Management
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Job Family:
Model Development and Analytics
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Time Type:
Full time
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Most Relevant Skills
Analytical Thinking, Business Acumen, Constructive Debate, Data Analysis, Escalation Management, Policy and Procedure, Policy and Regulation, Risk Controls and Monitors, Risk Identification and Assessment, Statistics.
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Other Relevant Skills
For complementary skills, please see above and/or contact the recruiter.
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Citi is an equal opportunity employer, and qualified candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law. 
If you are a person with a disability and need a reasonable accommodation to use our search tools and/or apply for a career opportunity review Accessibility at Citi. 
 
View Citi&rsquo;s EEO Policy Statement and the Know Your Rights poster.</div>

Regulatory Risk Model Development Analyst II

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