regulatory affairs analyst

Simpaisa

<div>
 Simpaisa a global consumer fintech firm, is looking for a Regulatory Affairs Analyst who will support the Global Head of Regulatory Affairs by researching, analyzing, and tracking changes in global regulations that impact Simpaisa operations. The analyst will play a critical role in ensuring that the companys policies are up-to-date and aligned with evolving regulatory requirements. This role will also assist in managing relationships with regulatory bodies.
 
 
 
 Key Responsibilities
 
 
 
 <ul>
 <li>
 Regulatory Research and Analysis:
 </li>
 <li>
 Conduct research on global regulatory developments in key jurisdictions.
 </li>
 <li>
 Monitor legislative and regulatory developments across key regions and fintech verticals.
 </li>
 <li>
 Analyze the impact of new and updated regulations on Simpaisa's operations and suggest the Global Head on necessary adjustments to compliance frameworks.
 </li>
 <li>
 Regulatory Risk Assessment:
 </li>
 <li>
 Assess potential regulatory risks and develop recommendations for mitigation strategies.
 </li>
 <li>
 Collaborate with internal teams to ensure the companys operations are adaptable to new regulatorychanges.
 </li>
 <li>
 Regulatory Reporting and Documentation:
 </li>
 <li>
 Assist in preparing regulatory reports, submissions, and filings required by government bodies and financial authorities.
 </li>
 <li>
 Ensure that all regulatory documentation is accurate, comprehensive, and in compliance with legal requirements.
 </li>
 <li>
 Track and report on the progress of regulatory matters and compliance projects.
 </li>
 <li>
 Support in Regulatory Affairs Initiatives:
 </li>
 <li>
 Assist in preparing presentations and reports for senior management on regulatory matters.
 </li>
 <li>
 Draft consultation responses, regulatory briefings, white papers, and position notes for internal and external audiences.
 </li>
 <li>
 Provide support for compliance audits, meetings with regulators, and policy discussions.
 </li>
 <li>
 Stakeholder Communication:
 </li>
 <li>
 Support the Global Head of Regulatory Affairs in liaising with policymakers, regulators, government agencies, and industry groups.
 </li>
 <li>
 Assist in managing Simpaisas regulatory relationships with external regulatory bodies and stakeholders.
 </li>
 <li>
 Regulatory Knowledge Management:
 </li>
 <li>
 Maintain a knowledge base of relevant regulatory frameworks and guidelines.
 </li>
 <li>
 Maintain a global regulatory watch-list and internal updates for executive and product teams.
 </li>
 <li>
 Ensure the company is aware of emerging regulatory trends and developments.
 
 
 
 </li>
 </ul>
 
 Key Performance Indicators (KPIs):
 
 
 
 1. Accuracy and timeliness of regulatory research and analysis.
 
 
 2. Number of regulatory changes tracked and reported.
 
 
 3. Number of successful regulatory submissions made on time.
 
 
 4. Stakeholder satisfaction with regulatory reports and communication.
 
 
 5. Number of risks identified and documented.
 
 
 
 Key Qualifications:
 
 
 
 Education: Bachelors degree in Law, or Master in Public Policy, Business, Economics, Finance,or a related field.
 
 
 
 Experience:
 
 
 
 <ul>
 <li>
 3+ years of experience in regulatory affairs, compliance, or legal analysis, preferably in the fintech or financial services industries.
 </li>
 <li>
 Experience drafting public policy papers and working with financial regulatory stakeholders.
 
 </li>
 </ul>
</div>

Regulatory Policy Analyst

Thermo Fisher Scientific

<div>Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you&rsquo;ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world&rsquo;s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions within an office setting, following a typical Monday to Friday work schedule. The ability to work in-office in Austin, TX is required for 50% of the time.
Discover Impactful Work
Join us to help build the future of science and healthcare by ensuring regulatory compliance in our innovative Animal Health product lines. The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities.
A day in the Life<ul><li>
Write, coordinate, compile, and submit regulatory documents to agencies, focusing on the USDA for the Animal Health product portfolio.</li><li>
Engage regulators in oral and written communications to discuss submissions, requirements, and address questions.</li><li>
Serve as RA subject matter expert, staying current on Animal Health regulations, guidance documents, notices, and competitor news.</li><li>
Coordinate regulatory issue resolution using internal resources, agencies, and outside consultants.</li><li>
Conduct trainings and communicate materials to enhance team knowledge of regulated environments.</li><li>
Review and approve labeling, packaging, advertising, and promotional materials for regulatory compliance.</li><li>
Participate in business meetings with internal collaborators and external partners.</li><li>
Collaborate with global regulatory professionals, providing guidance on strategies, submissions, and projects.</li></ul>
Keys to Success
Education<ul><li>
Minimum requirement of a Bachelor&rsquo;s degree in life sciences, bio-engineering or related science.</li></ul>
Experience<ul><li>
A minimum of 2-4 years of proven experience in Animal Health Diagnostic (preferred) or Human IVD Regulatory Affairs. This experience may include a combination of Animal Health VDx as well as US IVD and CE-IVD experience.</li><li>
Demonstrated ability to maintain regulatory permits and licenses.</li><li>
Proficiency in preparing regulatory compliance reports and performing regulatory surveillance.</li></ul>
Knowledge, Skills, Abilities<ul><li>
Experience in regulatory affairs, including strategy creation and development control.</li><li>
Outstanding attention to detail and time management skills.</li><li>
Excellent interpersonal, customer orientation, and presentation skills.</li><li>
Provided regulatory guidance on project teams.</li><li>
Detail-oriented for regulatory reviews.</li><li>
Skilled in multi-tasking and business impact</li><li>
Effective in matrixed environments and conflict resolution.</li></ul>
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!</div>

Regulatory Affairs Specialist - Animal Health (Austin, TX)

Amros Pharmaceuticals

Regulatory Affairs Officer.We seek a highly motivated individual with a Doctor of Pharmacy (PharmD) degree and 6 months to 1 year of experience in the pharmaceutical industry (Regulatory Affairs or a related function preferred).Key ResponsibilitiesAssist in compiling and submitting CTD/eCTD dossiers to health authorities.Support the coordination of responses to regulatory agency queries.Research and monitor global regulatory guidelines (ICH, FDA, EMA) for compliance.Maintain accurate regulatory documentation and archives.RequirementsPharmD degree.6-12 months of relevant pharma industry experience.Strong attention to detail and excellent communication skills.Job Type: Full-timeWork Location: In person

Regulatory Affairs Officer

NiSource

<div>Description
<h2 class="jobSectionHeader">Job Summary</h2>
Works with cross-functional teams to plan, prepare, research, analyze, litigate, and implement regulatory strategies and plans with each state's regulatory team to meet cost recovery objectives. Ensures rates are competitive, profitable, and comply with regulatory policies and guidelines. 
 
Supports accurate, timely, and innovative regulatory initiatives, including but not limited to: regulatory rate case filings, gas/fuel cost recovery filings, compliance filings, tariff filings, regulatory asset accounting, data analysis, and utility capital structure. Builds and maintains working relationships with Legal, Financial Planning, Accounting, and other departments to meet corporate regulatory strategic initiatives.<h2 class="jobSectionHeader">
Essential Functions</h2>
All levels may perform the following core responsibilities:<ul><li>
Develop strategies and work plans to ensure timely recovery of costs included in base rates and approved recovery mechanisms.</li><li>
Support analytical studies that recommend regulatory strategies to optimize revenue and return on invested capital.</li><li>
Prepare testimony and exhibits for regulatory applications; analyze intervenor testimony and assist with cross-examination strategies.</li><li>
Respond to data requests during rate cases and other petitions; support Commission hearings.</li><li>
Ensure timely and accurate development, interpretation, and input of approved rates into the customer billing system.</li><li>
Verify customer bills are correctly calculated.</li><li>
Provide comprehensive financial support, including accurate reporting of regulatory items in external filings, financial plans, and internal reports.</li><li>
Foster partnerships with internal departments such as Legal, Financial Planning, and Accounting.</li></ul><h3 class="jobSectionHeader">
Regulatory Analyst Responsibilities</h3><ul><li>
Compile, organize, analyze, and format data for cost recovery filings, base rate cases, and other regulatory reports.</li><li>
Provide fundamental rate interpretation and coordinate billing changes.</li><li>
Support other business units and project teams with regulatory needs.</li><li>
Assist in maintaining accurate financial records.</li><li>
Maintain awareness of state projects and customer service matters.</li><li>
Ensure seamless flow of information among team members.</li><li>
Embrace new technologies and continuous improvement.</li><li>
Prepare and perform SOX internal control testing.</li><li>
Perform duties under close supervision.</li></ul><h3 class="jobSectionHeader">
Senior Regulatory Analyst Responsibilities</h3><ul><li>
Includes Regulatory Analyst duties plus:</li><li>
Provide regulatory support to internal project teams and individuals.</li><li>
Interpret and analyze Commission regulations, rate orders, Staff reports, and intervenor positions.</li><li>
Coordinate external and internal audits.</li><li>
Lead billing implementation changes with IT and other internal groups.</li><li>
Assist Managers and Lead Analysts, including training of Regulatory Analysts.</li><li>
May provide expert testimony in support of filings.</li><li>
Coordinates tasks within assigned projects</li><li>
Provides technical support for responding to outside parties such as Commission Staff, Consumer Advocates, and legal counsel</li></ul><h3 class="jobSectionHeader">
Lead Regulatory Analyst Responsibilities</h3><ul><li>
Includes Senior Regulatory Analyst duties plus:</li><li>
Provide functional guidance to Regulatory Analysts.</li><li>
Offer expert technical regulatory advice.</li><li>
Lead projects and supervise project team members.</li><li>
Initiate studies of emerging issues and recommend strategic actions.</li><li>
Recommend approaches to preserve or enhance revenue.</li><li>
Prepare analytical regulatory studies and implement new procedures.</li><li>
Provide expert tariff interpretation and development across jurisdictions.</li><li>
Monitor energy industry trends and recommend strategic responses.</li><li>
Participate in negotiations and provide expert testimony.</li></ul><h2 class="jobSectionHeader">
Required Qualifications</h2><h3 class="jobSectionHeader">
Regulatory Analyst</h3><ul><li>
Bachelor&rsquo;s Degree in Accounting, Finance, Economics, or other business discipline</li><li>
Solid working knowledge of MS Office (Excel &amp; Word)</li><li>
Excellent verbal and written communication skills</li><li>
Strong attention to detail and technical skills</li><li>
Ability to work well in a team environment</li><li>
Demonstrated ability to be self-motivated</li></ul><h3 class="jobSectionHeader">
Senior Regulatory Analyst</h3><ul><li>
Includes Regulatory Analyst qualifications plus:</li><li>
Proven experience in the regulatory environment, financial planning, finance and/or accounting discipline</li><li>
Demonstrated ability to work with minimal supervision in an accurate and timely manner and deliver results</li></ul><h3 class="jobSectionHeader">
Lead Regulatory Analyst</h3><ul><li>
Includes Senior Regulatory Analyst qualifications plus:</li><li>
Demonstrated proficiency in multiple functions and successful assumption of increasingly technical projects and responsibilities</li><li>
Proven ability to provide expert technical advice to others in an accurate and timely manner</li><li>
Ability to successfully lead and coordinate projects and supervise project team members</li></ul><h2 class="jobSectionHeader">
Preferred Additional Qualifications</h2><ul><li>
Master&rsquo;s Degree / MBA</li><li>
Certified Public Accountant (CPA)</li><li>
Witness training and/or previous witness experience</li><li>
Familiarity with energy markets</li></ul><h2 class="jobSectionHeader">
Compensation Ranges</h2><ul><li>
Regulatory Analyst: $67,900 - $101,900</li><li>
Senior Regulatory Analyst: $79,800 &ndash; $119,600</li><li>
Lead Regulatory Analyst: $93,800 &ndash; $140,700</li></ul>
As a public utility, NiSource is required to provide continuous service to customers at all times. To ensure we fulfill that obligation, employees may be required to work outside their normal work hours and perform tasks outside of their normal responsibilities in support of emergency operations.
Work Authorization
Authorized to work in the United States without requiring sponsorship.
Workplace Connection 
Value inclusion within your day to day responsibilities by respecting others perspectives/convictions, engaging others opinions, creating a safe environment where people, ideas, and opinions are valued within your Team/Customers and external partners.
Respect the unique lived experiences within your Team/Customers and external work partners by valuing different world views, challenges, and cultures that represents all walks of life and all backgrounds.
Treat others with respect and consideration. Actively participate in creating and contributing to a positive work environment.
Equal Employment Opportunity 
NiSource is committed to providing equal employment opportunities in each of its companies to all employees and applicants for employment without regard to race, color, religion, national origin or ancestry, veteran status, disability, gender, age, marital status, sexual orientation, gender identity, sex (including pregnancy, lactation, childbirth or related medical conditions), genetic information, citizenship status, or any protected group status as defined by law. Each employee is expected to abide by this principle.
By applying, you may be considered for other job opportunities.
ADA Accommodations
If you need a reasonable accommodation to participate in any part of the hiring process or to perform the essential functions of the position, please contact OneHR at OneHR@nisource.com or 1-888-640-3320 
Safety Statement 
Promote a safe work environment by actively participating in all aspects of our employee safety program. Report any unsafe conditions and take actions to prevent personal injuries. Support our interdependent safety culture by ensuring the safety of your co-workers. Stay focused on the task at hand and promote productivity through good work habits.
E-Verify
NiSource participates in the U.S. Department of Homeland Security&rsquo;s E-Verify program. As part of this process, we provide the following notices to all job applicants: These documents inform you of your rights and responsibilities under U.S. law. You can view or download them using the links below:<ul><li>
E-Verify Poster (English and Spanish) E-Verify Participation Poster English and Spanish</li><li>
Right to Work Poster (English and Spanish) If you have the right to work, don't let anyone take it away</li></ul>
Salary Range*:
$93,800.00 - $140,700.00<ul><li>The salary offered to a candidate is based on several factors including but not limited to the candidate&rsquo;s skills, job-related knowledge, and relevant experience, as well as internal pay equity.
</li></ul>Posting Start Date:
2025-11-10
Posting End Date (if applicable):
2025-12-05 
Please note that the job posting will close on the day before the posting end date.</div>

Regulatory Analyst / Senior or Lead Regulatory Analyst

Besins Healthcare

Key Responsibilities:<ul><li>Acts as responsible Regulatory Team member for assigned regulatory projects.</li><li>Preparation and submit Life-Cycle Maintenance regulatory submissions for Africa (English and French Speaking).</li><li>Prepares and/or reviews regulatory documentation for National applications in line with assigned timelines.</li><li>May support on some R&amp;D regulatory projects.</li><li>Actively participates and employs effective communication practices with internal stakeholder (CMC, Supply Chain, Quality, Legal, Clinical, Medical, Pharmacovigilance, and Globally based Regional Regulatory affairs team</li><li>Understands the Scope of Work, timelines and deliverables for a given project.</li><li>Prepare status reports and metrics for assigned projects.</li><li>Perform assigned work according to current best good regulatory practice/guidelines in compliance with current legislation.</li><li>Any other duties as assigned by your manager.</li><li>Learn, develop, and train.</li></ul>_Technical Skills/ Experience_<ul><li>&gt;4-5 years pharmaceutical regulatory experience, focusing on lifecycle maintenance of marketed products in Africa, Middle East, Asia (e.g. variations, renewals, new Marketing Authorisation Applications (MAAs) submissions)-Europe/Turkey experience is and advantage.</li><li>Preparation of relevant CTD (Common Technical Dossier) documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling operations.</li><li>Experience of GCC markets/ICH guidelines/MHRA guidelines</li><li>Experience of emerging markets / international RoW markets and regulatory filings.</li><li>Quality control review of technical/ regulatory documents.</li><li>Understanding of Regulatory strategy and determination of documentation requirements. Compliance with SOPs, Change controls and regulatory best practices.</li><li>Publishing: eCTD and or NEES.</li><li>Pharmaceutical artwork review and sign-off.</li><li>Project management experience - an advantage.</li><li>Experience of Women s and/or Men s healthcare an advantage</li></ul>_Soft Skills_<ul><li>Ability to work to tight timelines and manage peaks in workload.</li><li>Good team player with internationally based colleagues in Global Pharmaceutical Affairs team.</li><li>Positive can-do attitude in growing company with expanding range of therapeutic product range.</li><li>Good negotiating skills and the ability to identify and resolve issues with external stakeholders.</li><li>Excellent verbal and written communication skills.</li><li>Excellent computer skills e.g. Word, Excel, data and document management systems.</li><li>Cultural awareness for global ways of working.</li><li>Able to act as a mentor to junior colleagues and to assist in their training and development as appropriate.</li><li>Desire to grow regulatory operational and regulatory strategy experience.</li><li>Languages: Speaking &amp; Writing French is a Must- Fluent Arabic/English Required as well.</li></ul>_Minimum required education and experience_<ul><li>Degree in Pharmacy or life science-related degree plus at least 4-5 year s relevant human pharmaceutical experience with focus on filing and lifecycle maintenance of marketed products in Middle East/ Africa/Asia</li></ul>

New Jersey Housing and Mortgage Finance Agency

<div><div><div><div><div>NOTICE OF VACANCY

THE EXECUTIVE DIRECTOR OF THE NEW JERSEY HOUSING AND MORTGAGE FINANCE AGENCY INVITES APPLICATIONS FROM QUALIFIED CANDIDATES FOR THE FOLLOWING:

Job Title: Legal Research Analyst II 
Salary Range: PR14 ( $88,762.25 - $124,898.78 ) 
Division: Regulatory Affairs 
FL Status: Exempt 
Issue Date: 11/10/25 
Closing Date: 12/31/25 
Union Status: Non-Union, Exempt 
Employment Status: Full time

JOB DESCRIPTION

Under supervision, review and analyze legal issues related to the HMFA including, but not limited to those involving confidential legal issues for the Agency and multi-family rental housing and single-family home-ownership loans; draft and promulgate HMFA regulations; perform research and draft memoranda; coordinate transfer of ownership and mortgage prepayment approvals and closings; respond to HMFA and public requests for information; coordinate litigation; respond to OPRA requests; assist in EEO matters; review contracts and other documents and perform related duties as required.<ul><li>
Assist in processing Open Public Records Act (OPRA) requests; coordinate and provide responses to requesters, consult with the Attorney General&rsquo;s Office as appropriate on related legal issues including matters of a Confidential nature and related other duties.</li><li>
Draft and promulgate regulations for the New Jersey Administrative Code, including relevant public notice and comment requirements.</li><li>
Provide litigation support for the Attorney General&rsquo;s office and assist with answering interrogatories and related matters on litigation handled by outside counsel. Coordinate, track and assist counsel representing the HMFA on litigation matters inclusive of working with Human Resources on Confidential litigation.</li><li>
Draft and review contracts and other documents. Perform research and draft memoranda. Complete assignments based on sound principles and an accurate understanding of HMFA statutes, regulations, policies and procedures.</li><li>
Review and analyze Agency legal issues, including, but not limited to those involving Multi-family rental housing loans and coordinate multi-family troubled project workouts and special projects. Locate and assemble necessary information and documents to resolve any problems concerning troubled projects and special projects. Work to complete the special project or conclude the workout by coordinating the work of Audit, Technical Services, Finance, sponsors and the sponsor's attorneys.</li><li>
Process requests by housing sponsors to use residual receipts and DCE (Development Cost Escrow), CDE (Community Development Escrow) or PSR (Project Subsidy Reserve) funds. Coordinate residual receipt requests.</li><li>
As needed, coordinate and process approvals and closings of transfers of ownership involving HMFA-financed projects, mortgage prepayments, and other Regulatory Affairs transactions. Responsibilities include document preparation, as well as making certain that all outstanding conditions are satisfied to finalize the closing. Coordinate with the Attorney General&rsquo;s office and sponsor to complete the required documentation.</li><li>
Resolve issues between HMFA staff and the Office of the Attorney General to complete requests.</li><li>
Prepares requests for Board action and presents to HMFA Board as required.</li><li>
As needed, assist in Equal Employment Opportunity (EEO) investigations and other EEO-related matters.</li></ul>
MINIMUM REQUIREMENTS
Education/Experience:
Level II (Range 14)
Juris Doctorate and five (5) years of relevant experience; Background in regulation development and procedure and/or real estate law preferred; or an equivalent combination of education and experience that meets the required knowledge, skills and abilities.
Certificates &amp; Licenses:
Admission to New Jersey Bar preferred.
A valid driver&rsquo;s license in the state in which the person resides is required only if the operation of a vehicle, rather than an employee mobility is necessary to perform the essential duties of the position.
Skills:<ul><li>Knowledge of HMFA statute and regulations.</li><li>Knowledge of OPRA law and procedures.</li><li>Knowledge of regulation promulgation process.</li><li>General knowledge of real estate documents and closing procedures, including municipal land use, construction requirements, and title requirements.</li><li>General knowledge of real estate appraisal methods, corporate/partnership formation documents, tax credit syndications, and bond financing requirements.</li><li>General knowledge of litigation practice.</li><li>Knowledge of HMFA administrative policies.</li><li>Knowledge of government funding programs.</li><li>Knowledge of legal research methods and procedures.</li><li>Ability to communicate effectively, both orally and in writing.</li><li>Ability to accomplish multiple assignments simultaneously.</li><li>Ability to draft in a legally proficient manner and format.</li><li>Ability to prepare accurate, concise and informative reports, and to perform financial calculations related to real estate transactions.</li><li>Ability to analyze information and make appropriate recommendations.</li><li>Ability to effectively work within and meet strict deadlines, particularly involving OPRA requests</li></ul>
Physical Demands: Non-physical
Working Conditions: General office environment

BENEFITS
<div>
NJHMFA provides a comprehensive benefit package which includes: 
<ul><li>Medical, prescription, dental, vision &amp; long term disability</li><li>FSA &amp; HSA</li><li>Public Service Loan Forgiveness and Tuition Reimbursement</li><li>Public Employees' Retirement System (PERS)</li><li>Deferred compensation plans</li><li>Employee assistance services (EAS)</li><li>State employee discounts program</li><li>Paid personal, sick and vacation days</li><li>Paid holidays</li><li>Partial Telework</li></ul></div>

Residency in the State of New Jersey is required of all employees with an agency of the State in accordance with the New Jersey First Act, N.J.S.A. 52:14-7 (L. 2011, Chapter 70). Employees must comply with the &ldquo;New Jersey First Act&rdquo; which requires employees hired after September 1, 2011 to reside in New Jersey. Non-New Jersey resident employees must relocate to New Jersey within one year of their date of hire and provide proof of residency to Human Resources.

The NJHMFA is an Equal Opportunity Employer in compliance with all Federal, State and Local Regulations. NJHMFA provides equal employment opportunity to both individuals with veteran status and individuals with disabilities.

Must complete an Outside Activity Questionnaire (disclosure of outside office or employment) on an annual basis.</div></div></div></div></div>

Legal Research Analyst II

Perrigo

<div>At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging. 
Join us on our One Perrigo journey as we evolve to win in self-care.<div><div><div><h2 class="jobSectionHeader"> 
Description Overview</h2></div><div>
In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products, and support in making correct and timely new product applications of Perrigo products on the Turkish market. You will support to ensure compliance with the existing legislation for Medicines, Medical Devices, Biocides and Cosmetics. Another key aspect of the role will be supporting in the achievement of the overall Regulatory, Quality &amp; Safety objectives and timely realization of operational activities. In this position you collaborate closely with the Corporate Regulatory and Turkish Commercial colleagues to strive to help the customer the best.</div></div><div><div><h2 class="jobSectionHeader">
Scope of the Role</h2></div><div><ul><li>
Support in the management of change by preparing applications and technical files in support of existing commercial product regulatory maintenance;</li><li>
Support in the regulatory activities on new product development (NPD), including artwork approvals, label claims and associated supporting documentation;</li><li>
Develop and approve label specifications (master text and local artwork text) in compliance with SOPs, as well as promotional materials from a regulatory perspective;</li><li>
Maintain regulatory files and data systems in compliance with SOPs;</li><li>
Represent regulatory affairs in project meetings with both Perrigo staff and external contacts;</li><li>
Follow up on changes in (inter)national regulations and legislations, and support in the interpretation, communication and implementation;</li><li>
Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the Turkish and/or European territory;</li><li>
Support in the communication with local regulatory authorities regarding license applications and notice of change.</li></ul></div></div><div><div><h2 class="jobSectionHeader">
Experience Required</h2></div><div><ul><li>
University Degree in a Scientific Subject;</li><li>
Minimum of 2 years work experience within Regulatory Affairs required, within at least one of the following categories Medical Devices, Biocides, Cosmetics and Medicines;</li><li>
Excellent communicator in Turkish and English;</li><li>
Proficient computer skills esp. Microsoft (word, excel, powerpoint); experience with Veeva, TVT, Trackwise is an asset;</li><li>
Eye for detail, punctual, well organized;</li><li>
Being flexible and adaptable to change;</li><li>
Ability to support several concurrent projects/products simultaneously;</li></ul></div></div></div>
Benefits 
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
Find out more about Total Rewards at Perrigo. 
Hybrid Working Approach 
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles. 
We are proud to be included in the Forbes list of &quot;America's Best Employers by State 2024&quot;. Find out more here 
Applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you. 
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo</div>

Regulatory Affairs, Associate Specialist

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