- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs, Strategic Labeling is responsible for ... staff for assigned therapeutic area(s). Responsibilities + Develops and directs regulatory labeling strategy planning for or across assigned product group… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare 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 position may serve as an ad hoc member of… more
- J&J Family of Companies (Raritan, NJ)
- …Clinical, Medical Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing labeling ... Associate Director , RA Labeling Product Leader (1...regulatory guidelines and their applications for guidance for labeling . + Experience leading project teams within a matrix… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** This position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... hoc member and independently provides strategic and operational leadership on new product labeling in collaboration with the Global Regulatory Leads (GRLs) and… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative Medicine is recruiting for Associate Director , ... At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be responsible for...critical review of submission documents to ensure compliance with regulatory requirements. + Participates in development of labeling… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …on real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs (Early Development) provides strategic global regulatory ... in the rare disease space. In this role, the Director defines and implements regulatory strategies; works...+ With support of Commercial RA, develops initial product labeling and assesses proposed product claim proposal (pre-NDA). +… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to ... Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance....Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and cross-functional team… more
- Bristol Myers Squibb (Madison, NJ)
- …. **Position Responsibilities** + Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion ... pharmaceutical products across therapeutic areas + Responsible for understanding the regulatory landscape, assessing regulatory risk, and developing global… more
- Bristol Myers Squibb (Madison, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life ... + Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities +...+ Provide strategic direction (and content input) on US Labeling + Anticipate and interpret key trends and changes… more
- Bristol Myers Squibb (Madison, NJ)
- …products/program. Act as the Safety Subject Matter Expert for input to regulatory product labeling . Participate/provide input at cross-functional labeling ... assigned products. Act as the Safety Subject Matter Expert for input to regulatory product labeling . Participate/provide input at cross-functional labeling … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a Director to join our Precision Medicine team. The Director , Precision Medicine will lead Companion Diagnostics (CDx) strategy working closely ... with Senior Director , Precision Medicine CDx and key cross-functional collaborators to...both externally and internally + Have relevant knowledge of regulatory requirements (including IVDR) and support regulatory … more
- AbbVie (Florham Park, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Senior Director Regulatory Affairs Therapeutic Area Head, GRS, is responsible for ... the management of global regulatory leads with product and disease state expertise for...portfolio + Strong experience working with multiple functions (Ad/Promo, Labeling , CMC, devices, Clinical development, etc.) and cross functional… more
- System One (Florham Park, NJ)
- …- Quality of Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory activities related to QOL initiatives. This role ... successful outcomes for our QOL initiatives. Responsibilities + Support the Senior Director in developing and executing regional regulatory strategies for QOL… more
- J&J Family of Companies (Raritan, NJ)
- Director , Medical Safety Officer (Neurovascular) - 2406209070W **Description** **Johnson & Johnson, is recruiting for a Director , Medical Safety Officer ... The MSO will build clear and positive relationships between R&D, Quality, Regulatory , Clinical, Epidemiology and Safety sciences and Safety process and groups to… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. **Summary** The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... Profile (TPP) + Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.)...Health Authority) + Participant and voting member in the labeling development process in the Labeling Working… more
- Sanofi Group (Bridgewater, NJ)
- …protocol, participates to the review process for protocols, study reports, labeling , and contributes/supports interactions with regulatory agencies and ethics ... you thought was possible. Ready to get started? The Clinical Research Director (CRD), Dupilumab, Immunology and Inflammation Therapeutic Area is responsible for the… more
- Vantage Specialty Chemicals (Fairfield, NJ)
- …in Personal Care and Cosmetics. This position will report directly to the Global Director Regulatory Affairs. The person will be responsible for personal care, ... documents such as SDS's, PCN (poison control notification), and CLP (classification, labeling and packaging), regulatory data sheets. + Monitor, interpret,… more
- J&J Family of Companies (Raritan, NJ)
- Associate Director , Signal Detection Scientist - 2406212640W **Description** Johnson and Johnson is currently seeking an **Associate Director , Signal Detection ... for signal detection and analysis of internal company safety data, international regulatory safety databases, and other data sources, eg, claims and electronic… more
- Organon & Co. (Jersey City, NJ)
- …promotional regulatory strategy in collaboration with Commercial, PRT, Global Regulatory Liaisons, Medical Affairs and Worldwide Product Labeling . + Guide ... development program. + Support BD due diligence efforts and define promotional regulatory risks of asset acquisitions and partnerships. + Leads cross-functionally to… more