- 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
- J&J Family of Companies (Raritan, NJ)
- …The Senior Director , URP will be pivotal in positioning Global Regulatory Affairs (GRA) as a forward-thinking, industry-leading strategic partner, ... The S enior Director , Global Leader Unified Regulatory...The ideal candidate will have a strong background in regulatory affairs , technology, and process optimization, as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …for bringing the issue and potential solutions to the Head of US Regulatory Affairs in conjunction with the assigned US RA strategist on the assets. This ... coordinating, mentoring, and providing guidance to direct reports (US RA strategists) across the alliance products to produce robust,...or working or resources to the Head of US Regulatory Affairs and/or 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
- Organon & Co. (Jersey City, NJ)
- **Job Description** **The Position** Reporting to the Director in Regulatory Chemistry, Manufacturing and Controls, the Senior Scientist is responsible for ... products in accordance with global regulations, guidance's and defined regulatory strategies. The Senior Scientist is responsible for the preparation… more
- Novo Nordisk (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... you ready to make a difference? The Position As Senior Medical Director for the novel modalities...Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive… 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 , 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
- Merck (Rahway, NJ)
- **Job Description** Under general supervision of an Executive Director / Senior Director , the Principal Scientist / Director is responsible for developing ... for projects of increasing complexity. + Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- As a Senior Director , HEOR you will be responsible for leading HEOR-Epidemiology activities to inform, support, and strengthen global development and ... drug designation, diversity plans, etc.) * Working cross-functionally with medical affairs , clinical development, regulatory affairs , pharmacoepidemiology *… 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
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …leaders, advisory boards), internal stakeholders (eg, Research, Regeneron Genetics Center, Regulatory Affairs , Global Clinical Development, Precision ... The Senior Medical Director , Clinical Development will...key stakeholders , including pre-clinical research, Regeneron Genetics Center, regulatory affairs , clinical operations, and others. This… 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
- JPMorgan Chase (New York, NY)
- …years' experience at a large financial institution, regulator or law firm leading regulatory affairs and/or engagements. + BA/BS or similar degree required. + ... status quo and striving to be best-in-class. As the Regulatory Strategy Director "RSD" for Asset &...team and for providing strategic advice and direction to senior LOB/function leaders concerning regulatory matters. This… 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
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and guide product strategy -- May include cross-functional collaboration with R&D, Medical Affairs , Market Access, Regulatory Affairs and Marketing + ... **Job Description Summary** The HEOR Associate Director - BU based is accountable for ensuring...BD while informing the broader scientific strategy with Medical Affairs . This role is accountable for de-risking the new… more