- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …on a broad range of healthcare regulatory matters, including regulatory labeling discussions, advertising and promotion, drug safety, market research, ... This position with the Regeneron Regulatory and Commercial Law team will provide proactive...to multiple internal stakeholders, including the commercial, medical affairs, regulatory , HEOR, corporate affairs, and compliance teams. Counsel will… more
- Sumitomo Pharma (Albany, NY)
- …clinical regulatory strategies including management of IND and NDA submissions, FDA and other global regulatory interactions, as well as international ... proposed claims and assess consistency of proposed claims with FDA -approved labeling + Provide regulatory leadership to...experience in preparing strategies for and submitting applications for drug or biologic products (INDs, NDAs, MAAs) + NDA… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …products and drug -device combination products. Ensure compliance with global regulations ( FDA , EMA, ICH, WHO) and anticipate regulatory changes impacting CMC ... **Job Summary** The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global … more
- Mount Sinai Health System (New York, NY)
- … Drug (IND) Applications and obtains approval from the Food and Drug Administration ( FDA ) for investigator-initiated clinical trials. Acts as primary contact ... **Job Description** A Senior Regulatory Compliance Coordinator position is currently available within...for all FDA communication, including submission of serious adverse events, amendments,… more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- … strategy, planning and execution of global investigational and marketed prescription drug submissions and manages lifecycle regulatory activities in alignment ... of the drug development process, laws, regulations, and guidelines including FDA , ICH, etc. - Able to successfully interpret and apply regulatory … more
- Otsuka America Pharmaceutical Inc. (Albany, NY)
- …of regulatory affairs experience. + Minimum 2-3 years' work experience in regulatory intelligence. + Previous interactions with FDA or other health authority ... The Associate Director of Regulatory Intelligence leads the collection and dissemination of...JPMA, etc.). + Demonstrate solid working knowledge of the drug , biologic, and device development process, laws, regulations, and… more
- GRAIL (Albany, NY)
- …Regulatory affairs and IVD device experience required. + Direct experience with FDA regulatory submissions required. + Demonstrated knowledge of US and ... 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …might be for you if:** + If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry ... The Senior Manager, Regulatory Affairs will report to the Global ...novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance… more
- Parexel (Albany, NY)
- …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
- Parexel (Albany, NY)
- …Adobe Acrobat, TVT, Promomats, and GLAMS. **Core Competencies:** + Knowledge of regulatory requirements relevant to drug development, global labeling, and ... markets? Parexel is seeking an experienced and highly motivated **Global Regulatory Labeling Lead** to provide strategic leadership and operational oversight for… more