- MD Anderson Cancer Center (Houston, TX)
- …will be responsible for the regulatory and quality oversight of MD Anderson's FDA regulated investigational products and applications. They will oversee a team of ... regulatory specialists responsible for advising MD Anderson's investigators on FDA submission requirements and pathways, develop investigational plans and protocols,… more
- Amneal Pharmaceuticals (Piscataway, NJ)
- Description: The Associate II (A), assists with minimal guidance, the Senior Director of Regulatory Affairs Clinical/ FDA Communications.Assists the Senior ... communications/ updates Essential Functions: + Assist the Senior Director of Clinical Regulatory Affairs/ FDA Communications...+ Assist in reviewing and ensuring standards for eCTD submissions + Manage and maintain the In Vitro Task… more
- Johns Hopkins University (Baltimore, MD)
- …faculty serving sponsor-investigators and their research teams in the development of their submissions to FDA . + Provides guidance for the regulatory submission ... IDEs in accordance with the JHU governing guideline. The IND/IDE Program Director will develop and maintain all operational functions that support IND/IDE activities… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …real-world evidence, and creating hope for all facing illness. The Director , Regulatory Affairs provides strategic global regulatory guidance to cross-functional ... and/or in the rare disease space. In this role, the Director defines and implements regulatory strategies; works with cross-functional project teams… more
- Sumitomo Pharma (Columbus, OH)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs** . The Associate Director is part of the ... This position is also responsible for providing internal expertise on FDA regulations governing promotion and advertising of assigned products. This position… more
- BeiGene (Emeryville, CA)
- …and EU (EMA). + Experience with global regulatory health authorities, including successful submissions and interactions with agencies such as FDA , EMA, and PMDA. ... The Executive Director of Regulatory Affairs, Companion Diagnostics (CDx) will...products, ensuring compliance with regulatory agencies such as the FDA , EMA, and other health authorities. This role will… 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 ... bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define,...as original NDA/BLAs. + Direct point of contact with FDA , leads and manages FDA meetings. Manages… 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 ... therapies to patients worldwide. Join Takeda as a Senior Director , Global Regulatory Lead, GI & Inflammation where you...point of contact with health authorities, leads and manages FDA meetings and/or other regional HA meetings as appropriate.… more
- Merck (North Wales, PA)
- **Job Description** Reports to the Director /Senior Director in the Office of Promotion and Advertising Review (OPAR) The Associate Director is responsible ... objectives. Serve as the liaison and manages correspondence with FDA 's promotional review divisions Office of Promotion and Advertising Review(OPDP)/Advertising… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Serve as the primary contact with FDA . + Lead and prepare FDA submissions , including but not limited to briefing documents, breakthrough therapy designation ... of our cutting-edge assets by effectively liaising, negotiating and partnering with FDA . This role will create and implement effective regulatory strategies to… 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
- 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
- Sanofi Group (Cambridge, MA)
- Director , Human Factors and Usability Engineer Location: Cambridge, MA or Bridgewater, NJ Hybrid work model- must be able to commit to 2-3 days onsite/week. **About ... peptides, genomics etc. and supports device product maintenance post launch. The Director , Human Factors and Usability Engineer will apply deep knowledge and… more
- Takeda Pharmaceuticals (Columbus, OH)
- …authority. + Thorough understanding of regulatory guidelines related to global submissions and submission content (eg, FDA /EMA/PMDA regulations; ICH guidance; ... best of my knowledge. **Job Description** **About the role:** **Associate Director , Nonclinical Regulatory Writing and Submission Support,** **_Oncology and Marketed… more
- AbbVie (Irvine, CA)
- …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
- Kelly Services (Ballwin, MO)
- …regulatory submissions and interactions with health authorities, including the FDA , EMA, and other regulatory bodies. + Experience with lifecycle management of ... Kelly Scientific is leading the search for a **Regulatory Affairs Director ** - a permanent role with a pharmaceutical company focused on discovery and development of… more
- Eurofins (Boston, MA)
- …US FDA 510(k), De Novo, PMA, and Breakthrough Device submissions . + Safety and Engineering Consulting: Evaluate product safety, engineering processes, and ... inclusion across the entire network of Eurofins companies. Position Overview: The Director of Consulting Services will lead and develop our consulting business,… more
- Reynolds American (Winston Salem, NC)
- …Strong interpersonal, collaboration, & relationship building skills + Experience with the FDA regulatory environment and regulatory submissions + Expertise in US ... Sr Director Population Health/Consumer Behavior Reynolds American is evolving...Global team of 15-2 **Core Relationships** **Internal** - Cross-functional: Submissions , Product Development, Marketing, Legal & External Affairs, Procurement,… more
- Providence (Burbank, CA)
- **Description** **THE ROLE** Under the direction of Executive Director of Quality provides day to day operational leadership for risk management, responsible for the ... with applicable regulatory agencies and the Joint Commission. The director will work very closely with the hospital Manager(s)...survey and reporting activities, including CDPH, DMH, DHS, CMS, FDA and the Joint Commission in collaboration with the… more