- Edgewell Personal Care (Allendale, NJ)
- …the Global R&D organization who oversees all activities related to regulatory compliance across all Edgewell's brand portfolio. Responsible for assessing, ... across the organization, as well as ongoing and future regulatory compliance planning and proof of cGMP. Lead the...of the consumer products industry. + Experience with OTC drug regulations for FDA, Health Canada, and TGA. Medical… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- … regulatory processes. Additional Responsibilities: + Maintain awareness of all regulatory activities regarding new and approved drug products. Stay current ... Description: Regulatory expert in the area of Biosimilar/BLA submissions...of Biosimilar/BLA submissions including strategize, compile, review and manage/lead regulatory submissions. Subject matter expert in the area of… more
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Leading the Regulatory Policy and Intelligence activities for Global Regulatory Affairs covering all Therapeutic Areas and ... of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization to guide product… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Regulatory Affairs (RA) Business Operations believe talented people deserve a ... Management + Change, Communications and Engagement + Performance Management + Regulatory Inspection and Standards Excellence (RISE) Management + Business Process… more
- Bristol Myers Squibb (Princeton, NJ)
- …marketing authorizations across the globe. PCO is looking for a Scientific Director , Drug Metabolism to lead biotransformation activities in Development DMPK ... strategies in 14C human ADME studies. + Understanding of regulatory requirements in the areas of drug ...of regulatory requirements in the areas of drug metabolism, drug - drug interactions, bioanalysis,… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- **Job Summary** **** The Associate Director , MSAT - Downstream provides specialized technical leadership and oversight for all downstream manufacturing processes ... review technical reports, protocols, risk assessments, and relevant sections of regulatory submissions (IND, BLA, MAA, etc.) related to downstream processing. +… more
- JPMorgan Chase (Jersey City, NJ)
- …they have access to the best possible care and resources. As the Executive Director , Prescription Drug lead within the Benefits Department at JPMorgan Chase, you ... will manage and enhance our Prescription Drug offerings and other benefits programs. Your role will...prescription drugs, dental and vision + Monitor legislative and regulatory changes to ensure compliance with new and existing… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …that advance R&D Project Team objectives and encompass drug substance, drug product, analytical, quality, regulatory , and clinical supplies. + Represents the ... some of the brightest minds in biopharma. **Position Summary** The Scientific Director /Senior Director , CMC Team Leader is responsible for developing and… more
- Bristol Myers Squibb (Summit, NJ)
- …s general support and leadership within the Global Product Quality organization . The Sr. Director a uthor s designated sections of regulatory filing s , review ... their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Senior Director , Cell Therapy Global Product Quality Lead ( Sr. Dir. CT-… more
- Otsuka America Pharmaceutical Inc. (Princeton, NJ)
- …robust business and technical relationships related to the development and manufacturing of drug products. The Director will be responsible for leading the ... scale-up, and technology transfer activities to ensure efficient and effective development of drug products. + The Director should be knowledgeable in managing… more