- 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
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for ... and supporting global needs as required. The RA Associate Director , Labeling will be overall responsible for...will be overall responsible for ensuring compliance with US regulatory requirements for labeling , and for coordinating… 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
- Takeda Pharmaceuticals (Trenton, NJ)
- …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 ... of labeling documentation and assures that Takeda labeling content and processes conform to regulatory ...Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… 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
- Bausch Health (Bridgewater, NJ)
- …reviews, approves and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. ... to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and determine the… more
- J&J Family of Companies (Trenton, NJ)
- Director , Global Regulatory Leader (GRL) (1 of 2)...and OUS markets. + Serve as a member of the Labeling Working Group to create or update the CCDS and ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Global Regulatory Affairs Leader (1 of...they are doing in early/late development and knowledge of labeling aspects + Impact and Influence: Able to persuade,… more
- J&J Family of Companies (Trenton, NJ)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory Medical ... potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a...Strategy Plan) through active participation at relevant meetings (eg, Labeling Working Group, Regulatory Strategy meetings, Functional… more
- Bristol Myers Squibb (Princeton, 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 (Princeton, 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 (Princeton, 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
- Novo Nordisk (Plainsboro, NJ)
- …on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% overnight travel required. Position is Home Office ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...ready to make a difference? The Position The Medical Director serves as the subject matter expert for our… 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
- J&J Family of Companies (Skillman, NJ)
- …Senior Associate, Regulatory Affairs, Dietary Supplements This position reports to the Director , Regulatory Affairs and is based in Skillman. **Who we are** ... Senior Associate , Regulatory Affairs - 2407025090W **Description** Kenvue is currently recruiting for:… 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
- Novo Nordisk (Princeton, NJ)
- …regulatory agencies. Supervise designated personnel. Relationships Report to the Director /Associate Director /Lead Regulatory Scientist/Sr. Manager ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… 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 (New Brunswick, 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
- Taiho Oncology (Princeton, NJ)
- Sr. Director , PV Medical Surveillance Princeton, NJ, USA Req #378 Monday, July 15, 2024 Looking for a chance to make a meaningful difference in the oncology space? ... Proposition: Embark on a transformative journey with Taiho Oncology as a Sr. Director , PV Medical Surveillance . At the forefront of pharmacovigilance innovation, we… more