Senior Manager Regulatory Affairs
3 days ago
Sun 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 handling publishing and coordinating tasks for Global RA submission activities.
Key Responsibilities:- Coordinate and manage various programs and projects for which SPARC GRA/GRO is responsible.
- Stay up-to-date with current Global Regulatory filing requirements and eCTD structure.
- Collaborate with Strategists, Publishers, and stakeholders on submission strategies.
- Track and schedule submission activity, providing reports to upper management.
- Validate and QC incoming and outgoing regulatory data/documents.
- Archival of submissions and documents.
- Review and QC final published submission documents before submitting to Health Authorities.
- Track archiving of global eCTDs, paper submissions, and Health Authority correspondences using Regulatory Affairs systems.
- Support and maintain authoring templates.
- Assist functional areas with document-level requirements and best practice techniques for compliant authoring.
- Participate in infrastructural activities, such as implementing new tools and systems required by the department.
- Track, generate, and present monthly snapshots and yearly metrics as applicable.
- Support maintenance and update of Health Authority Commitment trackers, including post-approval commitments for programs assigned to SPARC GRA/GRO.
- Associate or Bachelor's Degree required.
- 3-5 years' experience in publishing and related tools/eCTD requirements.
- Effective timeline management and communication skills relative to submission components.
- Flexible with strong spoken and written communication skills and ability to navigate diverse cross-cultural/cross-functional environments.
Sun Pharma is a leading provider of valued medicines, trusted by healthcare professionals and patients, to over 100 countries across the globe. Our Global Code of Conduct governs every aspect of our operations, and we are committed to making good health accessible and affordable to local communities and society at large.
We offer a comprehensive benefits package, including hybrid work arrangements, medical, dental, and vision benefits, health savings accounts, flexible spending accounts, prescription drug coverage, telehealth and behavior health services, income protection, retirement benefits, group life insurance, wellness programs, and corporate discounts on personal services.
-
Senior Manager Regulatory Affairs
6 days ago
US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full timeSenior Manager, Regulatory AffairsSun 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, supporting the Global RA submission process and...
-
US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full timeRegulatory Affairs Strategy Senior Director OpportunitySun Pharmaceutical Industries, Inc. is seeking a highly experienced Senior Director to lead our Regulatory Affairs Strategy team. As a key member of our global regulatory affairs team, you will be responsible for developing and executing the overall regulatory strategy for our novel drug development...
-
Senior Manager, Regulatory Affairs
3 weeks ago
Trenton, NJ, United States Sun Pharmaceutical Industries, Inc. Full timeCOME 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...
-
Strategic Regulatory Affairs Director
2 days ago
US-, Trenton, NJ , USA Sun Pharmaceutical Industries, Inc. Full timeSenior Director, Global Regulatory Affairs StrategyThe position will provide regulatory affairs strategic leadership for Sun Pharmaceutical Industries, Inc. and novel drug development programs. The individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway, interacting with...
-
US-, West Windsor Township, NJ, USA Sun Pharmaceutical Industries, Inc. Full timeJoin Our Team as a Senior Manager, Regulatory AffairsAt Sun Pharmaceutical Industries, Inc., we are committed to making good health accessible and affordable to local communities and society at large. We are seeking a highly skilled and experienced Senior Manager, Regulatory Affairs to join our team.About the RoleThe Senior Manager, Regulatory Affairs will...
-
Head of Regulatory Affairs
5 days ago
US-, Bridgewater, NJ , USA Actalent Full timeJob Title: Head of Regulatory AffairsActalent is seeking a seasoned regulatory affairs professional to lead our regulatory submissions and strategy. As a key member of our management team, you will be responsible for guiding the strategic direction of our development programs and ensuring they meet regulatory approval standards.Key Responsibilities:Lead...
-
Regulatory Affairs Senior Manager
3 weeks ago
McLean, VA , USA, United States Freddie Mac Full timeJob SummaryFreddie Mac is seeking a highly accomplished and motivated professional to join our Regulatory Affairs team as a Senior Manager. This role will provide strategic regulatory advice to senior management on all matters associated with FHFA's supervision across the enterprise.Key ResponsibilitiesLead multiple time-sensitive projects and facilitate...
-
Head of Regulatory Affairs
5 days ago
Bridgewater, NJ , USA, United States Actalent Full timeJob Title: Head of Regulatory AffairsWe are seeking a highly skilled and experienced Head of Regulatory Affairs to join our team at Actalent. As a key member of our management and product development leadership teams, you will play a critical role in advancing our company's portfolio and ensuring commercial success.Key Responsibilities:Lead our regulatory...
-
Head of Regulatory Affairs
4 days ago
Bridgewater, NJ , USA, United States Actalent Full timeJob Title:Head of Regulatory AffairsWe are seeking a seasoned regulatory affairs professional to lead our regulatory submissions and develop our company's regulatory strategy.This role will oversee the regulatory affairs and operations team, partnering closely with R&D, Technical Operations, and clinical development teams to advance our portfolio and ensure...
-
Regulatory Affairs Director
3 weeks ago
Bridgewater, NJ , USA, United States Proclinical Staffing Full timeAssociate Director, Regulatory Affairs, Advertising & PromotionProclinical Staffing is seeking an experienced Associate Director, Regulatory Affairs, Advertising & Promotion to join a global pharmaceutical company in New Jersey.Key Responsibilities:Review and approve prescription drug product advertising and promotional labeling pieces for compliance with...
-
Senior Manager, Regulatory Affairs
4 months ago
Princeton, NJ, United States Sun Pharma (Taro Pharma) Full timeCOME 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
1 month ago
Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full timeCOME 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
1 week ago
Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full timeCOME 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 One...
-
Regulatory Affairs Specialist
2 weeks ago
US-, United States Teleflex Full timeJob Title: Sr. Regulatory Affairs SpecialistTeleflex is seeking a highly skilled Sr. Regulatory Affairs Specialist to join our team. As a key member of our Global Operations organization, you will play a critical role in ensuring compliance with regulatory requirements for medical devices.Key Responsibilities:Develop and implement regulatory strategies for...
-
Director of Regulatory Affairs
3 weeks ago
California, USA, United States Bow and Arrow Holdings, LLC Full timeJob Title: Director of Regulatory AffairsWe are seeking an experienced Director of Regulatory Affairs to join our team at Bow and Arrow Holdings, LLC. As a key member of our organization, you will be responsible for developing and executing advocacy strategies that support distributed generation development on residential real estate in our target...
-
Sr. Director, Regulatory Affairs Strategy
3 weeks ago
HOPEWELL, NJ, United States Sun Pharmaceutical Industries, Inc. Full timeSenior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company 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 registration...
-
Director of Regulatory Affairs
4 days ago
Carlsbad, CA, USA, United States Ionis Full timeDirector of Regulatory AffairsIonis Pharmaceuticals, a pioneer in RNA-targeted medicines, seeks a seasoned Director of Regulatory Affairs to lead the commercial regulatory strategy for our first-ever wholly owned commercial program. As a key member of our Regulatory Affairs team, you will be responsible for formulating and implementing creative and robust...
-
Sr. Director, Regulatory Affairs Strategy
5 months ago
Princeton, NJ, United States Sun Pharma (Taro Pharma) Full timeSenior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company 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 registration...
-
Regulatory Affairs Director
3 weeks ago
California, USA, United States Planet Pharma Full timeJob Title: Regulatory Affairs Associate Director/DirectorPlanet Pharma is seeking a highly skilled Regulatory Affairs Associate Director/Director to join our team in South San Francisco, CA. This is a 6-month contract opportunity.Key Responsibilities:Develop and implement competitive and effective global regulatory strategies for oncology products, including...
-
Regulatory Affairs Director
5 days ago
Carlsbad, CA, USA, United States Ionis Full timeDirector of Regulatory AffairsIonis Pharmaceuticals, a pioneering company in RNA-targeted medicines, is seeking a seasoned Director of Regulatory Affairs to lead the commercial regulatory strategy for our first-ever wholly owned commercial program. As a key member of our Regulatory Affairs team, you will be responsible for formulating and implementing...