- GRAIL (Trenton, NJ)
- …advanced degree may count toward years of experience. + Direct experience with FDA regulatory submissions required. + Experience with regulatory submissions ... information, please visit grail.com . The role assists with regulatory strategy and the development of submissions in partnership...and activities to optimally position GRAIL products with the FDA and/or global health authorities. + Support the US… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Requirements** + In-depth understanding of US Food & Drug Administration ( FDA ) and European Medicines Agency (EMA) regulatory requirements and International ... the lives of patients for generations to come. As an Associate Director, Global Regulatory Affairs, you will act as the Regional Regulatory Lead on more… more
- Ascendis Pharma (Princeton, NJ)
- …and/or PMP desired. + A minimum of 8 years of experience: 5 years in drug , biologic and/or combination products in Regulatory Affairs and 3 years of experience ... Management activities within the pharmaceutical and/or biotechnology industries. Orphan drug experience preferred. + Familiarity with Regulatory framework… more
- Mondelez International (East Hanover, NJ)
- …drugs, Natural Health Products and Dietary Supplements. Complete and submit FDA drug listings and NHP applications and submissions/documents. Create ... for your respective categories and geographical area using your Scientific and Regulatory expertise. You advocate for our regulatory and scientific positions… more
- Parexel (Trenton, NJ)
- …and/or drug -device combination products are a plus) * Support regulatory leads in developing contingency plans for CMC-related scenarios * Represent CMC ... for a Senior Consultant * Proven success in preparing regulatory documentation for FDA , EMA, and Health...Health Canada (IND, NDA, DMF) * In-depth understanding of drug development, manufacturing processes, GMP, and regulatory … more
- Parexel (Trenton, NJ)
- …looking to draw upon their wealth of experience in clinical trial design and drug development to join Parexel's highly recognized Regulatory Strategy team! A ... At **Parexel** , we don't just support drug development-we help shape it. As a **Senior/Vice... regulatory applications. + Previous experience with a regulatory agency (such as the FDA or… more
- Merck (Rahway, NJ)
- …excellence + Ensure processes align with regulatory requirements for medical device and drug combination products (eg, FDA 21 CFR Part 820, ISO 13485, ISO ... process inefficiencies using operational excellence tools and ensuring alignment with global regulatory requirements (eg, FDA 21 CFR Part 820, ISO 13485,… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Director, US Regulatory Affairs - Advertising and Promotion (Hybrid) **Location:** Cambridge, MA Morristown, NJ **About the Job** Are you ready to ... of medicine? The race is on to speed up drug discovery and development to find answers for patients...helping our teams accelerate progress. As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with… more
- Bausch Health (Bridgewater, NJ)
- …SAP preferred + Knowledge of current Good Manufacturing Practices (GMP), Food and Drug Administration ( FDA ), and regulatory pharmaceutical marketing and ... + Collaborate cross-functionally with Trade Operations, Supply Chain, Finance, Quality, Regulatory Affairs, and Commercial teams to ensure alignment and issue… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …study design and complex analysis issues, FDA issues, and general drug development. + Reviews clinical, statistical, and regulatory literature for current ... values and will be responsible for providing statistical expertise/input in the drug development including clinical development plan and regulatory submission… more