- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …ensuring appropriateness throughout the product's lifecycle and across different indications. Represent Global Regulatory Affairs on the GPT ( Global ... responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the...pharmaceutical industry + 7 or More Years with direct regulatory affairs experience, including experience in … more
- Merck (Rahway, NJ)
- …We are seeking a Senior Director (Sr. Principal Scientist) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that ... drive our strategic priorities. **Summary, Focus and Purpose** The Senior Principal Scientist | Regulatory Affairs...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... agencies. + Reports to Associate Vice President, Executive Director , or Senior Director in...and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical… more
- J&J Family of Companies (Raritan, NJ)
- …the lifecycle of the product and is in alignment with the strategies of global regulatory affairs , the therapeutic area, commercial, regional functions and ... Associate Director , CMC Regulatory Affairs ...Associate Director , CMC Regulatory Affairs - 2406221330W **Description** Johnson...of a senior member of the CMC RA staff. + Strong knowledge of global … more
- AbbVie (Florham Park, NJ)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs , Strategic Labeling is responsible for ... strategy and product labeling (CCDS, US/EU labeling documents) at Senior level meetings ( Global Regulatory ...+ Preferred Education: Relevant Master's degree preferred. Certification in regulatory affairs a plus + Required Experience:… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …including working with contract manufacturing organizations CMO.** This position serves as the Regulatory Affairs ( RA ) CMC project representative to the CMC ... support of global submissions and this position serves as the RA CMC representative supporting company initiatives (liaison with PhRMA, USP, ICH, due diligence,… more
- System One (Florham Park, NJ)
- Senior Manager, Regulatory Affairs ...Life (QOL), plays a pivotal role in supporting the Senior Director in overseeing regulatory ... days onsite) 12-month contract (renewable) Overview The Contractor - Senior Manager, Regulatory Affairs -...QOL initiatives. Responsibilities + Support the Senior Director in developing and executing regional regulatory … more
- Novo Nordisk (Plainsboro, NJ)
- …information to internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director / Senior Director ... About the Department Our East Coast Global Development Hub brings together the best minds...Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs , Data Management, Biostatistics, Non-clinical, Medical… more
- Sanofi Group (Bridgewater, NJ)
- **Job title** : Senior Director , Marketing Operations NA GTMC **Location:** Bridgewater, NJ or Cambridge, MA (Hybrid role) **About the Job** We are an innovative ... up the decision making. We are seeking an experienced Senior Director of Marketing Operations to join...teams, including but not limited to Sales, Marketing, Medical Affairs , Legal, and Regulatory Affairs ,… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Patent Attorney (Parsippany, NJ) Date: Nov 4, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: ... people to make a difference with. **The opportunity** As ** Senior Director , Patent Attorney** , you'll lead...positions + Determine ANDA submission strategy, in collaboration with regulatory affairs + Support the IP litigation… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director Biosimilar Strategy Date: Nov 2, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals Job Id: 56832 **Who we ... on strategic decisions and workload associated with building the department. This Senior Director must have strong relationships and communication skills as… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Senior Director , Associate General Counsel, Transactions Date: Nov 9, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva Pharmaceuticals ... their interdependent functions, including R&D, intellectual property, supply chain, finance, and regulatory affairs . This role will also help oversee internal… more
- Organon & Co. (Jersey City, NJ)
- …The successful candidate will lead Regulatory Policy and Intelligence activities for Global Regulatory Affairs . This would cover all Therapeutic Areas ... all regions of the world of interest to Organon. **Responsibilities** + Provide Global Regulatory Policy and Intelligence insights to the organization and guide… more
- J&J Family of Companies (Raritan, NJ)
- …clinical operations, project management, quality monitoring & compliance, data management, global medical safety, biostatistics, regulatory affairs , clinical ... Data Monitoring Committee (IDMC) and adjudication meetings as needed + Assists Regulatory Affairs in determining requirements for any corrective actions or… more
- Novo Nordisk (Plainsboro, NJ)
- …the therapeutic area, help develop PRO and biomarker strategies. Relationships Reports to: Senior Director of the Liver Disease department. Work with the ... About the Department Our East Coast Global Development Hub brings together the best minds...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with… more
- J&J Family of Companies (New Brunswick, NJ)
- …humanity. Learn more at https://www.jnj.com/. **Job Description:** Reporting to the Senior Director , MedTech Supply Chain, Innovation and Quality Communications, ... Director , MedTech Innovation Communications - 2406170343W **Description** Johnson...forums. leading organizational and internal communications for scientific and regulatory affairs . **Key Responsibilities:** + Drive external… more
- Novo Nordisk (Plainsboro, NJ)
- …Area in certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical Director in developing agenda for and ... Plan (EGP), in collaboration with Senior Medical Director + Serve as NNI Medical Affairs ...the Executive Director + Represent NNI Medical Affairs on Global Core Medical Team (CMT)… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Implementing strategic and tactical plans to drive sustainable improvements. + Supports Regulatory Affairs in providing quality content and review of documents ... at key governance meetings whereby GCLP/GLP activities are being discussed ( Regulatory affairs , Research unit LT, GRDC etc.,) Effectively interacts… more
- Novo Nordisk (Plainsboro, NJ)
- …the safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior ... to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …state community. This role works with the Clinical Development, Clinical Operations, Regulatory Affairs , Program Management, and teams.* Interfaces with both ... Description: We are seeking a Medical Director , Migraine and Cluster Headaches, to join our...Migraine and Cluster Headaches, to join our US Medical Affairs team at Amneal Pharmaceuticals, Inc. The role serves… more