- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Responsible for leading and developing global regulatory strategy for assigned development projects. Represents ... global strategy. + Responsible for ensuring aligned global regulatory strategy is endorsed by GPT...relevant pharmaceutical experience including 5 years of experience within Regulatory Affairs + Knowledge of IND, NDA/BLA… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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...experience required + 4 or More Years of direct regulatory affairs experience, including US labeling experience… more
- Sanofi Group (Bridgewater, NJ)
- …the advertising and promotion of prescription drugs and biologics. Essential Functions + Represents Global Regulatory Affairs (US RA AdPromo) as a member of ... About the Role The Associate Director , US Regulatory Affairs ...Consults with senior management and provides input to the global organization as needed. + Contributes US RA AdPromo… more
- Sanofi Group (Bridgewater, NJ)
- …and Capabilities** + This individual is expected to competently and confidently represent Regulatory Affairs as a key member of cross-functional RC teams for ... The Associate Director RA serves as the regulatory lead on Review Committees (RCs). As the RC RA representative, work with brands on competitively positioning… more
- Bausch Health (Bridgewater, NJ)
- …regulatory agency guidance. **KEY ACTIVITIES/RESPONSIBILITIES:** + Manages or represents Regulatory Affairs on the promotional review committees for ... Bausch Health is a global company that develops, manufactures, and markets a...new regulations, guidance documents and enforcement letters. Updates the Regulatory Affairs advertising and promotion staff, review… more
- Bausch Health (Bridgewater, NJ)
- …and procedures to enhance efficiencies and compliance. + Works closely with the Regulatory Affairs labeling group regarding package insert changes to assess and ... Bausch Health is a global company that develops, manufactures, and markets a...and the ability to see business drivers outside of regulatory affairs + Working knowledge of the… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Director Regulatory Affairs will provide leadership on global regulatory activities for the assigned products. Responsibility will mainly focus ... on Clinical Regulatory filings and provide regulatory leadership on the project teams in this area. We are a hands-on culture so responsibilities will include… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** Leadership responsibility for global regulatory strategy to support the development of biomarkers, ... side) + **CDx RA Policy and Intelligence:** Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …or More Years in the pharmaceutical industry required. + 8 or More Years in regulatory affairs + Experience in providing regulatory strategic input into the ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- … Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device ... aspects of registration activities with a working knowledge of regulatory affairs , in the development of the...effectively in a multidisciplinary team. + Experience working with global regulatory agencies. + Demonstrated business acumen… more
- AbbVie (Florham Park, NJ)
- …can sit in our Lake County, IL or Madison, NJ offices. The Scientific Director for US Medical Affairs in CNS/Psychiatry provides specialist medical and ... with the scientific review, development, approval, execution, and communication of affiliate/area/ global medical affairs sponsored or supported clinical research… more
- AbbVie (Florham Park, NJ)
- …with the scientific review, development, approval, execution, and communication of affiliate/area/ global medical affairs sponsored or supported clinical research ... scientific, strategic and operational leadership and expertise into core medical affairs activities such as: generation of clinical and scientific data) (enhancing… more
- ADP (Roseland, NJ)
- **ADP is seeking a Senior Director , Government Relations** . This position reports to the head of ADP's Government Relations function within the Global ... lobbyists and is responsible for coordinating ADP's legislative and regulatory monitoring and advocacy; intelligence collection, analysis and communication; and… more
- Bausch Health (Bridgewater, NJ)
- …effective aesthetic care options to consumers and physicians alike. The Professional Affairs lead is accountable for the designing & executing Solta's education ... with outstanding collaboration and teamwork with key partners such as, Medical Affairs , Marketing, Sales, Compliance, Quality, KOLs, etc. This role is responsible… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. **Summary** The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... of Dossier Planning will report to Head of Global Regulatory Operations and be an active...Regulatory operations required. + 4 or More Years regulatory affairs including filing NDA and sNDA.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …strategies, activities and ways of working. This role will also work with the Global Regulatory Affairs Leadership Team (GRA-LT) to define DS' priorities, ... is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through...Qualifications** + 7 or More Years Experience in pharma Regulatory Affairs , with at least 3 years… more
- Sanofi Group (Bridgewater, NJ)
- …in regulatory policy efforts. Reporting through Region North America within Global Regulatory Affairs (GRA), the candidate will work collaboratively ... to have a positive impact on the environment advise internal stakeholders on evolving regulatory policy issues, and more! The Director will be a strong subject… more
- Sanofi Group (Bridgewater, NJ)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global ) especially ... the US regulatory post-marketing activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory … more
- Sanofi Group (Bridgewater, NJ)
- …pharmaceutical/biotechnology industry experience, including at least 4 years of relevant Regulatory Affairs experience (regionally and/or global ) especially ... + Leads the US regulatory activities. + As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead… more
- AbbVie (Branchburg, NJ)
- …and implementation of global regulatory strategy and representation of Regulatory Affairs on R&D project teams. Assures that regulatory strategies ... indications within a Therapeutic Area and supports the Manager ( Global Regulatory Lead (GRL), Associate Director...lieu of, plus at least 4 years' experience in Regulatory Affairs ; or . Education equivalent to… more