- Formation Bio (New York, NY)
- …FDA and EMA requirements for statistical practice, regulatory submissions , and health authority interactions. Experience in quantitative decision-making ... the PositionFormation Bio is seeking a highly skilled and experienced Senior Director , Biostatistics to join our dynamic team. This critical role will report… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions , including but not limited to briefing documents, breakthrough ... US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions , shortening...ensure that FDA receives timely and quality submissions , shortening the review process and leading to successful… more
- Formation Bio (New York, NY)
- …bring new treatments to patients faster and more efficiently.About the PositionThe Director of Clinical Trial Management is responsible for leading and overseeing ... executed efficiently, on time, and in compliance with all regulatory requirements. The Director will manage a team of Clinical Trial Managers (CTMs) and Clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …liaise, negotiate and orchestrate meetings and teleconferences with FDALead and prepare FDA submissions , including but not limited to briefing documents, ... of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to… more
- Merck & Co. (Rahway, NJ)
- …and with external suppliersAuthor and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under ... strategy.Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human… more
- Genmab (Plainsboro, NJ)
- …will be responsible to interface directly with the global health authorities (and US FDA ) as the primary contact for the company for assigned programs. This position ... and implemented including label improvement, health authority meetings, potential ROW submissions , supplemental BLA submissions , tracking of progress of PMRs… more
- Merck & Co. (Rahway, NJ)
- …and with external partners.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under ... CFR Part 421 CFR 82021 CFR 210/ 211EU Medical Device RegulationUSP USP FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the study during FDA , MHRA, EMA, and PMDA interactions, such as pre- submissions , end of phase 1/2, and inspectionsMay support the GCL in planning and executing ... Director , Clinical Development Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our ... pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs Liaison is responsible for development and implementation of… more
- Merck & Co. (Rahway, NJ)
- …sites, manufacturing investigations, process validation, and authoring of regulatory submissions . -Under the general scientific and administrative direction of ... Director in the CCFS group and working in conjunction...assessment (RA), control strategy, process comparability reports, and/or regulatory submissions (BLA/MAA/JNDA etc.).Adaptability and agility to prioritize and deliver… more
- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct ... to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead, GRAD Oncology. You will provide strategic and… more
- Takeda Pharmaceuticals (Boston, MA)
- …probabilities of technical success for the solutions. + Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct ... strategies in collaboration with their regional counterparts. **Accountabilities:** + The Director will be responsible for complex or highly complex or multiple… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …orchestrate meetings and teleconferences with FDA + Lead and prepare FDA submissions , including but not limited to briefing documents, breakthrough therapy ... of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to… more
- Walgreens (Deerfield, IL)
- …**Job Summary** Walgreens RWE Clinical Trials is seeking an experienced Medical Director role to provide medical oversight and leadership serving as Principal ... new clinical trials for the business. Major duties of the Medical Director are outlined below: **Job Responsibilities:** **Medical Business Leadership** + Provides… more
- Inovio Pharmaceuticals (Plymouth Meeting, PA)
- …knowledge of the relevant current requirements for medical device and combination product submissions to FDA , prior interaction or exposure with other key ... tools. For more information, visit www.inovio.com . Job summary The Senior Director , Regulatory Affairs, Combination Products will have a broad span of… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions , including but not limited to briefing documents, breakthrough ... US regulatory support; meet aggressive deadlines to ensure that FDA receives timely and quality submissions , shortening...ensure that FDA receives timely and quality submissions , shortening the review process and leading to successful… more
- Takeda Pharmaceuticals (Boston, MA)
- …timelines as per R&D and business objectives. + Accountable for all US FDA submissions and approvals for assigned programs. Works cross-functionally with RA ... submissions + Strong knowledge of global regulatory requirements and prior FDA interactions/ submissions experience + Ability to use precedent and previous… more
- System One (Florham Park, NJ)
- Job Title: Director , US Regulatory Affairs Location: Florham Park, NJ (50% hybrid) Type: contract Overview: Support the Global Therapeutic Area Lead (GTAL), ... Regulatory Affairs (Senior Director ) in developing and executing regulatory strategies for antimicrobial/ antifungal programs globally or within specific regions… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …in discussions with external and internal stakeholders. A typical day as an Executive Director might look like: + Responsible for the strategic company guidance on ... FDA and global regulatory requirements (affairs and CMC) for...Regulatory CMC function in preparing high-quality CMC related regulatory submissions and supports the Regulatory CMC leads in interactions… more
- AbbVie (North Chicago, IL)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Associate Director , RA Global Regulatory Strategy, US & Canada is responsible for ... product within a Therapeutic Area and supports the Global Regulatory Lead (GRL, Director ), in the development & execution of the regulatory strategy. Area of… more
