Current jobs related to Senior Regulatory Affairs Specialist - Princeton - Intellectt Inc

  • Senior Manager Regulatory Affairs

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Join Our Team as a Senior Manager, Regulatory AffairsSun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company, and we are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring the timely and successful submission of...

  • Regulatory Affairs Senior Manager

    4 days ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Unlock Your Potential in Regulatory AffairsSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Global Regulatory Affairs department, you will play a critical role in ensuring the timely and successful submission of regulatory documents to health authorities worldwide.Key...

  • Senior Manager Regulatory Affairs

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Manager, Regulatory AffairsJoin Sun Pharmaceutical Industries, Inc. as a Senior Manager, Regulatory Affairs and be part of a team that is dedicated to making good health accessible and affordable to local communities and society at large.About the RoleThe Senior Manager, Regulatory Affairs will be responsible for publishing and coordinating tasks for...

  • Senior Manager Regulatory Affairs

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    About UsSun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company that delivers high-quality, affordable medicines to patients worldwide.Job SummaryWe are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. The successful candidate will be responsible for publishing and coordinating tasks for Global RA...

  • Senior Regulatory Affairs Manager

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Join Our Team at Sun Pharmaceutical Industries, Inc.We are seeking a highly skilled Senior Manager, Regulatory Affairs to join our team at Sun Pharmaceutical Industries, Inc. This is an exciting opportunity to work with a global leader in the pharmaceutical industry.About the RoleThe Senior Manager, Regulatory Affairs will be responsible for handling...

  • Senior Manager, Regulatory Affairs Specialist

    1 week ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Join Sun Pharmaceutical Industries, Inc. as a key member of our Regulatory Affairs team!We are seeking a highly skilled Senior Manager, Regulatory Affairs to handle publishing and coordinating tasks for Global RA submission activities. This role will support the Global RA submission process and infrastructure.Must be able to multi-task and coordinate for...

  • Senior Manager Regulatory Affairs

    4 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job OverviewSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Global Regulatory Affairs department, you will be responsible for publishing and coordinating tasks for Global RA submission activities.Key Responsibilities:Coordinate and manage various programs and projects...

  • Senior Director, Regulatory Affairs Strategy Lead

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs Strategy **Job Summary** We are seeking a highly experienced Senior Director, Global Regulatory Affairs Strategy to provide regulatory affairs strategic leadership for our company and novel drug development programs. **Key Responsibilities:** * Develop and execute novel drug regulatory strategy * Ensure...

  • Senior Director, Regulatory Affairs Strategy

    1 week ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job SummaryThe Senior Director, Regulatory Affairs Strategy will provide strategic leadership for the company's regulatory affairs and novel drug development programs. This role will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway, interacting with regulatory agencies, and ensuring...

  • Senior Director, Regulatory Affairs Strategy Lead

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job Title:Senior Director, Regulatory Affairs StrategyJob Summary:We are seeking a highly experienced Senior Director, Regulatory Affairs Strategy to provide strategic leadership for our company's regulatory affairs and novel drug development programs. The successful candidate will be responsible for developing and executing the overall regulatory strategy,...

  • Senior Director Regulatory Affairs Strategy

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the...

  • Senior Director Regulatory Affairs Strategy

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the...

  • Senior Manager Regulatory Affairs Specialist

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    About Sun Pharmaceutical Industries, Inc.Sun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company that provides high-quality, affordable medicines to patients worldwide.Job Title: Senior Manager, Regulatory AffairsJob SummaryThe Senior Manager, Regulatory Affairs will be responsible for handling publishing and coordinating tasks for...

  • Senior Director, Regulatory Affairs Strategy

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Regulatory Affairs StrategyThe position will provide strategic leadership for the company's regulatory affairs and novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway, interacting with regulatory agencies, and being...

  • Regulatory Affairs Specialist

    4 days ago

    Princeton, New Jersey, United States Avance Consulting Full time

    Job Title: Regulatory Affairs ManagerJob SummaryWe are seeking a highly skilled Regulatory Affairs Manager to support our client in the preparation and submission of Clinical Trial Applications (CTAs) within the EU Clinical Trial Regulation (CTR) framework.Key Responsibilities:* Prepare and submit CTAs within the EU Clinical Trial Integrated System (CTIS)...

  • Senior Manager Regulatory Affairs Professional

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Job OverviewSun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for publishing and coordinating tasks for Global RA submission activities.Key Responsibilities:Coordinate and manage various programs and projects for...

  • Senior Director, Regulatory Affairs Strategy Lead

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Strategic Regulatory Affairs LeadershipThe Senior Director, Regulatory Affairs Strategy will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. This position will be responsible for developing and executing the overall regulatory strategy, including developing the registration pathway,...

  • Senior Director Regulatory Affairs Strategy Lead

    2 weeks ago

    Princeton, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs StrategyAs a key member of our team at Sun Pharmaceutical Industries, Inc., you will play a critical role in shaping the company's regulatory affairs strategy for novel drug development programs. Your expertise will be instrumental in ensuring compliance with ICH and local country regulatory requirements, as well as...

  • Senior Manager, Regulatory Affairs

    1 month ago

    PRINCETON, United States Sun Pharmaceutical Industries, Inc. Full time

    p>COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE!Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA)  Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - 401k Company Match on Day...

  • Senior Manager, Regulatory Affairs

    4 months ago

    Princeton, United States Sun Pharma (Taro Pharma) Full time

    COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE! Hybrid work arrangement Medical, Dental, Vision Benefits Health Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug Coverage Telehealth and Behavior Health Services Income Protection – Short Term and Long Term Disability Benefits Retirement Benefits - 401k Company Match on...

Senior Regulatory Affairs Specialist

3 months ago

Princeton, United States Intellectt Inc Full time

Role: Senior Regulatory Affairs Specialist

Location: Princeton, NJ - 08540

Duration: 12+ Months


Core job responsibilities for this role may include:

This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for regulatory affairs activities, including directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports. Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR. Identify opportunity for regulatory affair processes and drive changes to completion.

Compile, prepare, and review regulatory submission to US and EU.

Anticipate regulatory obstacles and emerging issues throughout the product submission cycle and develop solutions with other members of regulatory and related teams

Provide regulatory input for responsible countries/region for product lifecycle planning

Monitor applications under regulatory review, and communicate application progress to internal stakeholders

Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities

Utilize technical regulatory skills to propose strategies on complex issues

Identify emerging issues for responsible countries/region

Assess the acceptability of quality, preclinical and clinical documentation for submission filing

Provide registration impact assessment in responsible countries/region for design changes

Provide strategic input and technical guidance on regulatory requirements to development teams

Ensure external communications for regulatory purposes meet regulations.


Minimum experience / training required:

5+ years’ experience in a regulated industry (e.g. medical devices, pharmaceuticals).

PREFERRED QUALIFICATIONS:

Individuals with “hands-on”/authoring experience with US 510k submission or EU MDR/IVDR technical files.

Individuals with practical experience working with in vitro diagnostics medical devices.

Practical experience in leading cross-functional team on regulatory and compliance related projects.