regulatory affairs coordinator

Peergrowth Consultancy Co.

<p>We are seeking a detail-oriented and proactive Regulatory Affairs Coordinator to support regulatory activities at our UAE-based manufacturing facility. This role is responsible for compiling and coordinating product and site-specific regulatory dossiers for submission to global health authorities, including support for GMP audits. The ideal candidate will collaborate closely with Quality Assurance (QA), manufacturing, and technical teams at the site, as well as regional regulatory teams. Experience with local UAE and GCC regulatory requirements is preferred, with an understanding of global CTD requirements.</p><p><b>KEY RESPONSIBILITIES</b></p><ul><li>Collate, compile, and review regulatory dossiers for product and site registrations in various international markets, including GMP audit dossiers.</li><li>Ensure accuracy, completeness, and regulatory compliance of all documentation submitted.</li><li>Review and verify the correctness and regulatory alignment of Artwork (AW) prior to submission.</li><li>Act as a key liaison between regional regulatory teams and site-based technical functions (QA, QC, Production, Engineering).</li><li>Coordinate technical responses and ensure timely resolution of queries raised by health authorities during or post submission through regional RA teams.</li><li>Maintain an organized and up-to-date archive of all regulatory submissions made from the site.</li><li>Implement proper version control, submission tracking, and document retrieval protocols.</li><li>Monitor submission timelines and follow up with internal teams to ensure timely completion of deliverables.</li><li>Ensure alignment with both international regulatory expectations and local UAE / GCC requirements.</li><li>Provide regular status updates on submissions and queries to the Head of International Regulatory Affairs.</li><li>Support documentation requests for internal audits, inspections, and compliance reviews.</li></ul><p><b>CANDIDATE EXPERIENCE</b></p><ul><li>Bachelors or masters degree in pharmacy (preferred)</li><li>2 to5 years of experience in Regulatory Affairs, ideally in a manufacturing or site-based setting within the pharmaceutical industry.</li><li>Preferred : Experience with handling guidelines of UAE Ministry of Health (MoHAP), GCC-DR, Oman, Bahrain, or other Gulf regulatory bodies.</li><li>Practical knowledge of CTD / eCTD dossier formats and GMP audit preparation.</li></ul><p><b>Key Skills and Competencies</b></p><ul><li>Strong communication, collaboration, and coordination skills across technical and regulatory functions.</li><li>High level of accuracy, attention to detail, and document management capabilities.</li><li>Ability to manage multiple priorities, meet deadlines, and adapt to dynamic regulatory requirements.</li><li>Proficient in Microsoft Office (Word, Excel, PowerPoint) and document control systems.</li><li>Proactive approach to problem-solving and handling regulatory queries.</li></ul><p>Coordinator • Dubai, United Arab Emirates</p><img src="https://www.jobg8.com/Tracking.aspx?zVcfVDlfDotLNFq0K%2b68Cho%2fqss4iFlXs" width="0" height="0" />

Regulatory Affairs Coordinator

Cigalah Gulf Medical

<p><b>Job Opening: Regulatory Affairs Officer / Coordinator</b></p><p>Location: Kingdom of Bahrain</p><p>We are looking for a Regulatory Affairs Officer / Coordinator to join our growing pharmaceutical team. The ideal candidate will play a key role in ensuring our company&rsquo;s full compliance with NHRA regulatory requirements, supporting product registrations, renewals, and quality-related operations.</p><p>Qualifications &amp; Requirements:</p><ul><li>Bachelor&rsquo;s Degree in Pharmacy (BS Pharmacy)</li><li>Must possess a valid NHRA license (Bahrain)</li><li>4&ndash;5 years of proven experience in Regulatory Affairs within the pharmaceutical industry</li><li>Solid understanding of NHRA and GCC regulatory guidelines and procedures</li><li>Experience in Quality Assurance (QA), Quality Systems, and Regulatory Compliance</li><li>Excellent knowledge of dossier preparation, submission, and tracking</li><li>Strong organizational and documentation skills with keen attention to detail</li><li>Good communication and interpersonal skills</li><li>Must be currently residing in Bahrain</li><li>Able to join immediately</li></ul><p>Key Responsibilities:</p><ul><li>Prepare, compile, and review regulatory dossiers for product registration, renewals, and variations in compliance with NHRA/GCC requirements</li><li>Liaise effectively with NHRA officials and other health authorities to ensure timely approvals</li><li>Maintain and update product licenses, certificates, and technical documentation</li><li>Ensure regulatory compliance for all marketed pharmaceutical products</li><li>Support internal and external audits, quality reviews, and inspection readiness activities</li><li>Collaborate with cross-functional departments (QA, Supply Chain, Production, etc.) to ensure adherence to company and regulatory standards</li><li>Stay up to date with changing regulations, guidelines, and industry trends affecting product registration and compliance</li></ul><p>Job Type: Full-time</p>

Regulatory Coordinator

Minerva Research Solutions

<div><b>Company Overview:</b><br>
<br>
Minerva Research Solutions is a clinical trial management service provider. We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle.<br>
Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines &amp; real-time solutions. Our clinical trial support services &amp; consultations are tailored to foster your product and requirements.<br>
<br>
We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.<br>
<br>
<b>Job Purpose:</b><br>
<br>
The Coordinator - Regulatory Affairs is responsible for working as a team member of regulatory professionals in ensuring regulatory compliance of company products and activities, including the preparation and submission of regulatory documents, the management of regulatory inspections, and the development and implementation of regulatory strategies.<br>
<br>
<b>Key Responsibilities:</b><ul><li>
Working as a regulatory professional to ensure effective and efficient regulatory support for the company's products and activities.</li><li>
Develop and implement regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelines.</li><li>
Manage the preparation and submission of regulatory documents, including regulatory filings, registrations, and certifications.</li><li>
Coordinate and manage regulatory inspections and audits, and ensure appropriate corrective and preventive actions are taken in response to any findings.</li><li>
Keep abreast of changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders in a timely manner.</li><li>
Build and maintain positive relationships with regulatory authorities and other external stakeholders.</li><li>
Provide regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance.</li><li>
Collaborate with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectives.</li><li>
Ensure timely and accurate reporting of regulatory activities and metrics.</li></ul><b>
Qualifications:</b><ul><li>
Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy.</li><li>
01 years of experience in regulatory affairs, fresh graduates will also be preferred</li><li>
In-depth knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated products.</li><li>
Excellent communication, interpersonal, and problem-solving skills.</li><li>
Ability to work independently and manage multiple projects simultaneously.</li><li>
Strong attention to detail and accuracy.</li><li>
Experience working in a fast-paced, deadline-driven environment.</li></ul><b>
Benefits:</b><ul><li>
Competitive salary and performance-based bonuses.</li><li>
Medical health insurance coverage.</li><li>
Employees Old-age benefits coverage.</li><li>
Professional learning and development support.</li><li>
Generous vacation and paid time off.</li><li>
Employee assistance programs for mental health.</li><li>
Company-sponsored events and team-building activities.</li><li>
Diverse, professional, and inclusive work environment.</li><li>
Opportunities for career growth.</li><li>
Cutting-edge technology and tools.</li><li>
Family-friendly policies, including parental leave.</li><li>
Commuter benefits or transportation assistance.</li><li>
Social responsibility and community involvement programs.</li></ul><b>
Openings:</b><p>
04 positions<br>
Full-time<br>
On-site job<br>
<br>
<b>Work Schedule Timings:</b><br>
Monday to Friday<br>
Evening Shift (07 PM to 03 AM)<br>
(transport facility provided for female staff only and allowance for male employees, additional night shift allowance)</p><p>
</p><p>z4hNZ1iI38</p></div>

Regulatory Co Ordinator(Evening Shift)

Pfizer

<div><div>JOB SUMMARY</div><div>
Colleague fundamentally performs the ePALMS system &ldquo;Market Coordinator&rdquo; role in close collaboration with the Global Regulatory Sciences (GRS) Strategy functions at Pfizer Country Offices (PCOs) and is the central Regulatory point of contact for the PGS plants/Artwork Centers (AWC). Colleague operates from a subject matter expert (SME) centralized &ldquo;hub&rdquo; capacity and in some cases, may perform Regulatory Strategist roles &amp; responsibilities where specific tasks are delegated and in line with local and global SOPs/Work Instructions.</div><div></div><div>
As a seasoned &ldquo;Market Coordinator&rdquo; within ALIM these colleagues perform all activities of their more junior level peers including:</div><ul><li>
Initiation and &ldquo;build&rdquo; of Pfizer Artwork Requests (PARs) in collaboration with local markets, assuring all required information, specifications and/or supportive documentation is available for plants/AWCs to execute the production of product Labeling related packaging components.</li><li>
Negotiating Artwork Change Control logistics across multiple Pfizer departments (as well as multiple markets) to assure Regulatory timelines for Implementation are met and that product supply is not interrupted.</li><li>
Tracking Artwork, Key Performance Indicators (KPIs) (e.g. volume, timelines, and/or quality metrics) for assigned projects as well as broader regional or ALIM department deliverables when required. Accountability for Final Label Content rests with the PCOs or functions creating content.</li><li>
Research into root cause assessments for internal ALIM Quality Investigations or Area Quality Review Team (AQRT) meetings, identify opportunities for continuous improvements and prepare formal recommendations to ALIM leadership when appropriate.</li><li>
Retrieving documents and/or generating reports in response to queries from Regulatory Agencies (e.g. inspections) or Assistant General Counsel (e.g. product litigation cases related to Labeling in distribution).</li></ul><div></div><div>
However, incumbents may be tapped to represent ALIM on various cross-functional projects, or<br>
sometimes lead ALIM continuous improvement teams. This could involve coordination of activities<br>
of other ALIM staff or contractors for the duration of the project.</div><div></div><div>
JOB RESPONSIBILITIES</div><div>
Liaises with markets and stakeholders to gather all necessary information to initiate and &ldquo;build&rdquo; PARs<br>
(according to local or regional requirements) to enable plant production of Labeling Artwork with minimal rework and to meet implementation requirements.</div><div><br>
May create Editor&rsquo;s Copy (EC) for select markets depending on language(s) involved and specific &ldquo;custom&rdquo; services negotiated with markets in line with local SOPs.</div><div><br>
Liaises with GRO GLM/ILG functions, GRS PCOs and PGS AWCs, or demand management lines to<br>
coordinate any unique factors that need to be considered; documents agreement on Artwork timelines across stakeholders; escalates any issues/concerns within ALIM functional line and/or relevant leadership for adjudication as necessary.</div><div><br>
Performs ePALMS &ldquo;Market Coordinator&rdquo; role, according to agreed timelines and established procedures, by performing the following activities, which include:</div><ul><li>
Evaluates content of labeling updates and raises potential issues with GRS, PGS or relevant local markets as appropriate to minimize impact on schedules.</li><li>
Evaluates PGS sites impacted by labeling updates.</li><li>
Initiates PARs in collaboration with assigned market(s); ensures attributes (system metadata) are correct, and ensures all relevant Regulatory documents are included and routed for any shared packs, assures that agreed upon content is received in appropriate format and is either reflected in a combined EC or as a separate EC for each market according to regional agreements and relevant job aids.</li><li>
Uses Biopharmaceutical Packaging &amp; Artwork knowledge, in combination with Trade Dress Style Guides, Country Specific Requirements and/or other appropriate guidelines while collaborating with PGS AWCs to assure accurate packaging component ECs; escalates issues or concerns if/as needed.</li><li>
Sends PARs to all relevant PGS sites; monitors and follows up on any aging PARs as needed.</li><li>
Upon receipt of final draft Artwork, reviews proofreading report and resolves any technical formatting questions or errors; assures necessary proofreading of final printed artwork against EC is completed using appropriate tools; escalates any issues, questions or errors within ALIM functional line or appropriate markets for adjudication as needed.</li><li>
Initiates, manages and tracks any necessary rework.</li><li>
Identifies appropriate Market Approvers for Packaging Artwork and electronically routes for approval using ePALMS lifecycle management; monitors progress and follows up as needed with appropriate PGS AWCs or GRS PCOs to assure agreed timelines are met and any Regulatory content issues that arise during the approval process are addressed.</li><li>
Tracks and communicates final approved labeling to list of relevant departments and stakeholders following final market review and signoff.</li><li>
Uploads any locally reconditioned or repackaged Artworks into ePALMS using &ldquo;dual role&rdquo; system capabilities to assure correct Artworks are available for next revision cycle.</li><li>
Leads teams in development and revisions of relevant SOPs for functional area.</li><li>
Works with minimal direct supervision; provides training and support to other team members or external vendors as required.</li><li>
Oversees work of other internal temporary personnel or external vendor staff as needed, tracks progress, monitors deliverables and intervenes if necessary; considers and adjudicates questions, assures volume, timeline, and/or quality performance metrics are met.</li><li>
Participates on cross-functional systems development and/or process improvement projects as<br>
assigned; contributes and/or advises teams in responding to new or revised legislation, regulations<br>
or guidelines for assigned market or region.</li></ul><div></div><div><br>
QUALIFICATIONS/SKILLS</div><div>
Demonstrated experience with:</div><ul><li>
Document management tools used for storage, retrieval, lifecycle management and tracking, of Labeling related secondary packaging components (e.g. ePALMS, GLAMS, BLUE, GDMS, Agile, PfLEET or similar systems).</li><li>
Business Analytic tools used for tracking and reporting of product Labeling, Artwork or submissions (e.g. Business Objects, Spotfire, Tableau, Business Objects or similar reporting tools).</li><li>
Document review, copy editing or proofreading tools (e.g. Docu-Proof, TVT or similar tools).</li><li>
Some exposure to project management tools and processes (e.g. MS Project, Business Charters, Quad Charts, RACI, etc.)</li><li>
Working in an international role with broad exposure to different regulations and cultures</li></ul><div></div><div>
Education &amp; Experience:</div><div></div><div><i>
Manager Level:</i> Bachelor&rsquo;s degree in an appropriate discipline, plus 6&ndash;8 years related work experience (at least 2-3 years of which are preferred to have been in a Labeling Artwork Change Control &amp; Implementation Management capacity or in roles such as Regulatory Strategy, Demand Management, Quality Operations or Supply Chain capacity which have frequent interactions with ALIM related specifically to Artwork Change Control and Implementation.</div><div><br>
NOTE: <i>Substantial additional relevant experience may be considered in lieu of degree; or an advanced</i><br>
<i>degree in an appropriate relevant discipline may be considered in lieu of some experience.</i></div><div><br>
Additional Qualifications/Attributes:</div><ul><li>
Must be familiar with Biopharmaceutical Regulatory environment and cGMPs associated with manufacturing, packaging &amp; distribution processes as well as a basic understanding of Artwork &amp; Labeling regulations and controls.</li><li>
Must be able to collaborate with cross-functional Pfizer teams, negotiate across globally distributed affiliates and manufacturing site personnel, and communicate across multiple levels of the organization in a clear professional manner.</li><li>
Solid PC business software skills including document authoring, spreadsheet, database management, and presentation applications are required</li><li>
Strong written and verbal communication skills required</li><li>
Strong English language skills are required of non-native English-speaking colleague to enable global interactions.</li><li>
Multi-lingual skills are highly desirable at all levels.</li><li>
Must be able to work under pressure of tight timelines, apply sound judgment in ambiguous business situations, appropriately assess issues for potential impacts and ability to escalate if/as needed.</li><li>
Strong demonstrated project management and organizational skills.</li><li>
In-depth knowledge of PGS manufacturing and site processes/requirements.</li><li>
Must have capacity to solicit input in ambiguous business situations, resolve conflicting feedback and make appropriate business decisions.</li><li>
Attention to detail and ability to research and respond to audit/inspection queries.</li><li>
Ability to travel (Domestic and/or International) is required.</li></ul><div></div><div>
ORGANIZATIONAL RELATIONSHIPS</div><div>
This is a project management and troubleshooting role that Liases between local Pfizer Markets and<br>
relevant Manufacturing Plants or AWCs to assure timely implementation of artworks for labeling on<br>
packaging components according to local Regulatory Agency requirements.</div><div></div><div>
Colleague coordinates Artwork Change Control workflows for assigned products, markets and vendors. In this role colleague also negotiates Artwork Implementation requirements across clusters of markets with conflicting requirements and may sometimes work across regions.</div><div></div><div>
Colleagues liaise between key Packaging and Labeling Artwork stakeholders such as Global Regulatory Affairs (GRA), Global Labeling Management (GLM), International Labeling Group (ILG), Pfizer Global Supply (PGS) plants as well as relevant PGS Demand Management functions to coordinate. They often take the lead in negotiating Regulatory timelines for Artwork Implementation on Product Labeling and associated packaging components, taking into account conflicting drivers across markets and/or stakeholders to assure Regulatory requirements are met and product supply is not impacted.</div><div></div><div>
This role is an individual contributor and as such, has no direct reports or budget/cost center management responsibility.</div><br>
Work Location Assignment: Hybrid<div></div><div><br>
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.</div><div></div>
Regulatory Affairs</div><div></div>

Packaging & Labeling Artwork Manager

Temple University Health System

<div></div><div><div><p>Temple University&rsquo;s Lewis Katz School of Medicine&rsquo;s Pulm/Critical Care/SleepMed Department is searching for a <b>Regulatory Program Coordinator</b> to join our team</p><p><b>
Become a part of the Temple family and you will have access to the following:</b><br>
<b>Full medical, dental, vision coverage</b><br>
<b>Paid time off</b><br>
<b>11 Paid Holidays</b><br>
<b>Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE</b><br>
<b>A generous retirement plan and so much more!</b></p><p><b>
Salary Grade: T25</b><br>
Learn more about the &ldquo;T&rdquo; salary structure.</p><p><b>
Salary Range: $50,000.00-$55,000.00</b></p><p><i>
This role is also eligible for our employee referral program-TERP! Current employees can earn up to $500! Conditions apply. Please contact the HR Employment office for details.</i></p><div><b>
Job Details:</b><br>
<ul><li>This position will be on-site</li><li>This position requires the following background checks: Cash Handling</li><li>This is a grant funded position</li></ul></div><p><b>
Position Summary:</b><br>
The Regulatory Program Coordinator under the supervision of the Regulatory Manager, participates in the coordination of active Phase I-IV clinical trials and interacts with study sponsors, PI&rsquo;s, and research clinical staff in the Lewis Katz School of Medicine&rsquo;s Thoracic Medicine &amp; Surgery department.</p><p>
At Temple, you will find it easy to fit in while staying true to yourself. We value what makes each employee unique and strive to maintain a culture of diversity and inclusion. As an employee, you will enjoy our collaborative team-based culture that values innovation and creativity.</p><p>
Click here to learn more about the benefits of working at Temple University.</p><div><b>
Required Education and Experience:</b><br>
<ul><li>Bachelor&rsquo;s degree and at least three years of experience in research and/or regulatory compliance in a research or clinical setting.</li><li>An equivalent combination of education and experience may be considered.</li></ul></div><div><b>
Responsibilities:</b><br>
<ul><li>Assists to maintain the oversight of all regulatory compliance monitoring including internal and external progress reports</li><li>Prepares and processes all regulatory documentation through the IRB including new submissions, continuing reviews, amendments, adverse events and reportable events</li><li>Organizes and maintains all regulatory affairs documentation/files</li><li>Supports compliance and quality assurance activities</li><li>Participates in site visits, monitoring, audit and close out visits</li><li>Participates in study team meetings, other required group meetings, and ongoing protocol training/compliance meetings</li><li>Assists in the development of investigator-initiated protocols, assists with IND applications and annual reports</li><li>Assists with regulatory compliance guidance oversight of investigator initiated multi-center trials</li><li>Trains research personnel on consent process/forms and the regulatory processes and regulatory documents.</li><li>Performs other duties as assigned</li></ul></div><div><b>
Required Skills &amp; Abilities:</b><br>
<ul><li>Demonstrated knowledge and understanding of complex federal regulations, ethical issues, institutional policies, and other federal agency requirements governing human subjects research.</li><li>Demonstrated knowledge of quality assurance or auditing functions.</li><li>Demonstrated computer skills, and proficiency with MS Word, MS PowerPoint, MS Access or similar software programs.</li><li>Excellent interpersonal and customer service skills, along with the ability to effectively collaborate with a diverse constituent population.</li><li>Excellent verbal and written communication skills, including training skills.</li><li>Demonstrated organizational and time management skills, along with the ability to work under tight deadlines.</li><li>Demonstrated ability to be detail-oriented.</li><li>Demonstrated ability to work independently and as part of a team.</li><li>Must maintain a working knowledge of current regulations, guidelines, and trends influencing the conduct of human subjects research.</li><li>Ability to travel to off-site locations that may not be accessible via public transportation.</li></ul></div><div><b>
Preferred:</b><br>
<ul><li>Experience with biomedical human research is preferred.</li></ul></div><p><b>
Temple University</b> is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status.</p><p><b>
Compliance Statement:</b> In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact.</p><p><b>
Temple University's Annual Security and Fire Safety Report </b>contains statistics, policies, and procedures related to campus safety. Click here.</p><p>
You may request a copy of the report by calling Temple University&rsquo;s Department of Public Safety at 215-204-7900.</p></div></div><p></p>

Regulatory Program Coordinator

Amgen

<b>Career Category</b> Sales &amp; Marketing Operations <b>Job Description</b> <p> <b>HOW MIGHT YOU DEFY IMAGINATION?</b> </p> <p> <b>Live</b> </p> <p> <b>What you will do</b> </p> <p>Let s do this. Let s change the world. In this vital role, you will manage country-specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance :</p> <ul> <li> <p>Ensures regulatory submissions are made on time and meet Amgen s corporate and local regulatory requirements</p> </li> <li> <p>With close supervision, implements the filing plan (MA and Lifecycle maintenance) for their countries, where applicable</p> </li> <li> <p>Reviews promotional and non-promotional materials</p> </li> <li> <p>Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner</p> </li> <li> <p>Partners with Regulatory Affairs Lead to support the regulatory development, registration, and lifecycle management of all Amgen molecules</p> </li> <li> <p>Partners with peers to ensure consistency on procedures</p> </li> <li> <p>Assists locally in Healthcare Compliance activities, where applicable</p> </li> <li> <p>Participates in local regulatory process improvements, initiatives, and training</p> </li> <li> <p>Establishes regular contacts and interactions with Distributors (if applicable).</p> </li> </ul> <p> <b>Win</b> </p> <p> <b>What we expect of you</b> </p> <p>We are all different, yet we all use our unique contributions to serve patients. The Sr Regulatory Affairs professional we seek is a teammate with these qualifications.</p> <p> <b>Preferred Qualifications:</b> </p> <ul> <li> <p>Degree and in-depth regulatory experience of the Gulf Markets (1-2 years experience)</p> </li> <li> <p>Depth knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.</p> </li> <li> <p>Experience interacting with regulatory agency in the Gulf markets</p> </li> </ul> <p> <b>Thrive</b> </p> <p> <b>What you can expect of us</b> </p> <p>As we work to develop treatments that take care of others, we also work to care for our teammates  professional and personal growth and well-being.</p> <p>In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.</p> <p> <b>Apply now</b> </p> <p> <b>for a career that defies imagination</b> </p> <p>Objects in your future are closer than they appear. Join us.</p> <p> <b>careers.amgen.com</b> </p> <p></p>

Sr Congress & Events Coordinator

CenExel Clinical Research

<p></p><div><p><b>About Us:</b></p><br>
<p>
</p><p>Each of CenExel&rsquo;s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.</p><br>
<p></p>
<p>
Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.</p><br>
<p></p>
<p><b>
Job Summary:
</b></p><p>With moderate oversight the Regulatory Coordinator I is responsible for the preparation, organization and implementation of regulatory research documents such as pre-study activities, initiation, execution, and reporting on the various status of research tasks in accordance with FDA guidelines, ICH GCP and SOPs. Maintain regulatory documents in accordance with applicable regulations and coordinate required investigator and study staff training.</p><br>
<p></p>
<p><b>
Essential Responsibilities and Duties:</b></p>
<ul>
<li>Collects, prepares, and submits documentation to various sponsors/CROs during study start-up, including:</li>
<li>o Submission documents/approvals</li>
<li>o Protocol amendments with respective signature pages</li>
<li>o Informed consent documents</li>
<li>o FDA form 1572</li>
<li>o Lab normal result documents</li>
<li>o financial disclosure forms</li>
<li>o Delegation of authority logs</li>
<li>o Licenses</li>
<li>o Reports</li>
<li>o Logs (e.g., temperature logs, drug accountability logs, master subject logs, screening and enrollment logs, specimen logs, etc.)</li>
<li>Collects, prepares, and submits documentation to institutional review boards for all ongoing and new trials.</li>
<li>Serve as a liaison between the IRB, site, and investigator.</li>
<li>Obtain necessary signatures from investigators and staff.</li>
<li>Maintains and tracks current staff credentials (i.e., CV, certifications, etc.)</li>
<li>Maintains and distributes new and revised regulatory documents to applicable site staff and applicable corporate teams.</li>
<li>Refers necessary regulatory questions to Sr. Regulatory Coordinator, Regulatory Manager or Regional Regulatory Manager.</li>
<li>Maintains regulatory documents for ongoing trials, and ensures all appropriate regulatory documents are archived at the conclusion of the study.</li>
<li>Submits applicable subject facing documents for translations.</li>
<li>Maintains current Clinical Conductor Regulatory information.</li>
<li>Prepares appropriate reports for submission as required to the IRB including Serious Adverse Events (SAE&rsquo;s), protocol deviations and other required reports.</li>
<li>Completes onboarding of new Investigators, including CV creation, obtaining medical license, and training documents.</li>
<li>Ensures the regulatory binder is ready for monitor review during monitor visits. Meets with monitor, as necessary.</li>
<li>Assists with regulatory inspections and sponsor audits as necessary.</li>
<li>Performs close-out duties including preparing the final report to the IRB and ensuring all original documents are filed in the regulatory binder. Ensures all appropriate regulatory documents are archived at the conclusion of the study.</li>
<li>Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies.</li>
<li>Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.</li></ul><br>
<p></p>
<p><b>
Education/Experience/Skills:</b></p>
<ul>
<li>Must be a high school graduate or have GED equivalency.</li>
<li>0-2 years of experience in clinical research regulatory affairs.</li>
<li>Demonstrated prioritization and organizational skills to efficiently and effectively, providing accurate information in a timely manner.</li>
<li>Ability to prioritize workload to meet demands of PI, coordinators, sponsors, and IRBs.</li>
<li>Demonstrated interpersonal skills to work with physicians, administrators, work colleagues, representatives from sponsors and others to achieve maximum efficiency in reaching and maintaining workplace goals in a professional manner.</li>
<li>Ability to understand work may be delegated by more than one person, depending on the individual needs of the clinical study and to carry out job responsibilities as assigned in a timely manner.</li>
<li>Computer skills using PC platform computers with proficiency in Excel and Word to enter data and generate correspondence accurately.</li>
<li>Ability to learn and become proficient in eRegulatory systems, IRB portals, vendor portals and sponsor portals.</li>
<li>A critical thinker with strong attention to detail and superb problem-solving abilities.</li>
<li>Must be able to effectively communicate verbally and in writing.</li></ul><br>
<p></p>
<p><b>
Working Conditions
</b></p><div><ul><li>Indoor, Office environment.</li></ul>
<ul><li>Essential physical requirements include sitting, typing, standing, and walking.</li></ul>
<ul><li>Lightly active position, occasional lifting of up to 20 pounds.</li></ul>
<ul><li>Reporting to work, as scheduled, is essential.</li></ul>
<ul><li>Ability to work overtime, weekends, and/or holidays as needed.</li></ul>
<ul><li>Ability to travel as needed.</li></ul>
<ul><li>Remote work arrangement depending on location.</li></ul></div><br>
<p></p>
<p>
CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.</p><p></p><p>
Equal Opportunity Employer<br>
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.</p></div>

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