- J&J Family of Companies (Titusville, NJ)
- Associate Director , RA Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an Associate ... + Lead the development, revision, review, agreement, and maintenance of primary labeling (the Company Core Data Sheet (CCDS), United States Package Insert (USPI)… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... responsible for the development and implementation of labeling content and strategy of multiple assigned products in various stages of drug development, which may… more
- Ascendis Pharma (Princeton, NJ)
- …workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling ... States and the Americas and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for ensuring compliance with… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic ... and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs). This...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** +… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Signal Detection Scientist - 2406212640W **Description** Johnson and Johnson is currently seeking an ** Associate Director , Signal ... event data reviews, evaluations of drug safety issues, adverse event dictionaries, core labeling , and Periodic Safety Review preparation * Ability to lead projects *… more
- Bristol Myers Squibb (Princeton, NJ)
- …or GRL as needed + Provide strategic direction (and content input) on US Labeling + Anticipate and interpret key trends and changes in the global/US regulatory ... environment and provide strategic guidance regarding development plans as a result. + Foster positive relationships with FDA. + Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion &… more
- Bristol Myers Squibb (Princeton, NJ)
- …with HA deadlines. + Contribute in the developing of target labeling . **Degree / Experience Requirements** + Bachelor's degree required; advanced scientific ... degree preferred (Masters, PhD, PharmD, BSN, etc.) with 5 years in the industry with at least 4+ years of US Medical Device Regulatory Affairs experience **Key Competencies** + Experience in successfully leading teams; ability to broadly represent the… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard ... problems of some complexity. This position makes decisions with consultation. **Responsibilities:** + **Planning for Development :** Manages multiple CMC development projects. Leads submission teams with supervision. Acts as point of contact to… more
- J&J Family of Companies (Skillman, NJ)
- Senior Associate , Regulatory Affairs - 2407025090W **Description** Kenvue is currently recruiting for: Senior Associate , Regulatory Affairs, Dietary Supplements ... This position reports to the Director , Regulatory Affairs and is based in Skillman. **Who...**Pay: 84k- 152k** **What you will do** The Senior Associate , Regulatory Affairs is responsible for developing regulatory strategy… more
- Novo Nordisk (Princeton, NJ)
- …The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance ... regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager Regulatory… more