- J&J Family of Companies (Titusville, NJ)
- Associate Director , Global Labeling Product Leader - 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)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Labeling Lead where you will be responsible ... international standards and guidelines. You will provide strategic and tactical labeling expertise to teams while ensuring compliance with applicable regulatory… more
- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... 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)
- …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...hoc member of Global Project Team (GPT) to address labeling issues for late stage projects. This position manages… more
- Sanofi Group (Bridgewater, NJ)
- The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning ... to Commercial teams during the development, review and approval of product labeling and advertising materials. + Work directly with Commercial teams from concept… more
- Bristol Myers Squibb (Princeton, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Summary:** The role of Associate Director of US Commercial Regulatory Affairs requires the ... Ensure full regulatory compliance of all promotions with approved labeling and /or FDA guidances. + Ensure regulatory compliance...guidance as appropriate on the development of draft product labeling to ensure commercially viable US labeling … more
- Sanofi Group (Bridgewater, NJ)
- About the Role The Associate Director , US Regulatory Affairs (RA) serves as the regulatory lead on relative Review Committees (RCs), for products in the Rare ... US RA AdPromo input to the development of optimal FDA product labeling on original and supplemental New Drug Applications and/or Biologics License Applications.… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Monday, April 22, 2024 Looking for a chance to make a meaningful difference in ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the...Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other applicable documents for clinical trials. +… more
- Novo Nordisk (Princeton, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide strategic ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions + Provide… more
- Sanofi Group (Bridgewater, NJ)
- …of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of ... products + Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations + Ensure that respective regulatory team members have the information necessary to… more
- Sanofi Group (Bridgewater, NJ)
- …of Global Regulatory Project Strategy (GRPS) and ensures alignment with the core product labeling for products in development as well as for life cycle management of ... products + Participates in the development and monitoring of the global regulatory environment and updating of standards and processes related to drug and biologics regulations + Ensure that respective regulatory team members have the information necessary to… more
- Novo Nordisk (Plainsboro, NJ)
- …overflow in other areas as needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in other ... with colleagues. Essential Functions + Therapeutic Area: + Assist Manager/ Director in review of labeling for marketed...ability to work with less direct supervision than at Associate level + Willingness and ability to identify and… more
- Novo Nordisk (Plainsboro, 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …working within established timelines of investigational product manufacturing, labeling , release, distribution and return/destruction, and/or helping to establish ... of RFP, assumptions and SOW for CROs and IP services vendors ( labeling , packaging, distribution; IVRS/IWRS) + Provides input, reviews, and approves vendor study… more
- Integra LifeSciences (Princeton, NJ)
- …to help improve outcomes. **SUPERVISION RECEIVED** Under direct supervision of Associate Director , Global Marketing - Surgical Reconstruction, TT **SUPERVISION ... product line extensions and/or line trimming, forecasting, pricing strategies, labeling revisions, clinical studies, manufacturing and customer service/operations support… more
- Merck (West Point, PA)
- …contract execution, and ongoing contract management. This role will report to the Associate Director to provide high quality strategic analysis of data to ... and Clinical Supply) for clinical supply chain services (comparators, packaging, labeling , distribution, & onsite FTE's). This includes strategic sourcing of… more