- Bristol Myers Squibb (New Brunswick, NJ)
- …to address external questions regarding drug products. The CMC Regulatory Associate Director , Biologics is responsible for content development, compilation, ... personal lives. Read more: careers.bms.com/working-with-us . The GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a… more
- HCA Healthcare (Nashville, TN)
- …Do you want to join an organization that invests in you as a Senior Director Regulatory and Accreditation? At HCA Healthcare, you come first. HCA Healthcare has ... cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free...a difference. We are looking for a dedicated Senior Director Regulatory and Accreditation like you to… more
- Regeneron Pharmaceuticals (Troy, NY)
- The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls (CMC) quality and compliance excellence ... standards for all CMC operations across Regeneron. As a Director of CMC Industry and Regulatory Intelligence,...industry trends, for relevance and impact to internal processes, drug development projects and/or regulatory strategies and… more
- Corewell Health (Grand Rapids, MI)
- Job Summary - Director , Medical Regulatory and Accreditation Collaborates with the VP and senior leadership of Priority Health's Medical Management and ... to the medical policy life cycle. Essential Functions - Director , Medical Regulatory and Accreditation + Responsible...team members, patients, visitors, and community. We require a drug -free workplace and require team members to comply with… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …determination, and development of clinical and regulatory documents used in drug development and product registrations. The Director offers clear guidance, ... Director , Therapy Area Head, Global Regulatory ...expertise. Considered an internal expert in all aspects of regulatory medical writing and clinical drug development.… more
- Charles River Laboratories (CA)
- …that you can feel passionate about. **Job Summary** We are seeking anexperienced ** Director of Regulatory Services & Compliance** to join our **Insourcing ... in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will...San Diego, CA, or San Francisco, CA.** As the ** Director of Regulatory Services & Compliance** ,… more
- HCA Healthcare (Nashville, TN)
- …Do you want to join an organization that invests in you as a(an) Director Regulatory and Accreditation? At HCA Healthcare, you come first. HCA Healthcare ... cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free...make a difference. We are looking for a dedicated Director Regulatory and Accreditation like you to… more
- Lilly (Indianapolis, IN)
- …life better for people around the world. Purpose: The purpose of the Senior Director /Executive Director , Global Regulatory Affairs, Global Regulatory ... drug /device clinical development and knowledgefromhealth authorities such as regulatory policies, regulatory precedents, trends, and emerging regulatory… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …plans to facilitate timely drug development and registration. The Senior Director , Regulatory Affairs - Clinical also works directly with cross-functional ... and creating hope for all facing illness. The Senior Director , Regulatory Affairs - Clinical (Neuroderm), may...external service providers or suppliers directly involved in the drug development process. + Provides leadership and guidance by… more
- J&J Family of Companies (Columbus, OH)
- Director , Regulatory Medical Writing (1 of 4) - 2406211847W **Description** Johnson & Johnson is currently seeking a Director , Regulatory Medical ... potential. At Johnson & Johnson, we all belong. The Director , Regulatory Medical Writing (RegMW) is a...applications is required. + Knowledge of the clinical end-to-end drug development process is required. + Strong content awareness… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. As an Associate Director , Global Regulatory Affairs Marketed Products you will define, develop ... experience. + Preferred experience in reviewing, authoring, or managing components of regulatory submissions. + Solid working knowledge of drug development… more
- J&J Family of Companies (Spring House, PA)
- Associate Director , North America Regulatory Lead - 2406196976W **Description** Johnson & Johnson Innovative Medicine is recruiting for Associate Director , ... At Johnson & Johnson, we all belong. The Associate Director , Regulatory Affairs will be responsible for...health regulated industry experience. + An understanding of the drug product lifecycle from discovery to clinical trials to… more
- Ascendis Pharma (Princeton, NJ)
- …a dynamic workplace for employees to grow and develop their skills. The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling ... labeling, and for coordinating internal labelling activities and processes for regulatory submissions and product maintenance. The Associate Director prioritizes… more
- Takeda Pharmaceuticals (Lexington, MA)
- …true to the best of my knowledge. **Job Description** Join Takeda as an Associate Director , US Advertising & Promotion Regulatory Review out of our Lexington, MA ... guidance, and enforcement trends governing the promotion of prescription drug and biologic products. + Provide regulatory ...prescription drug and biologic products. + Provide regulatory strategic oversight for at least one (1) complex… more
- Takeda Pharmaceuticals (Lexington, MA)
- …order to bring life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Global Regulatory Affairs CMC where you will develop and lead ... CMC team, you will report to a Senior Director and work with stakeholders across the business. **How...can be considered). + Understanding of scientific principles and regulatory CMC requirements relevant to global drug … more
- Ascendis Pharma (Palo Alto, CA)
- …dynamic workplace for employees to grow and develop their skills. The Associate Director , Regulatory Affairs will be responsible for developing and implementing ... drug -device combination products preferred. + Experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with marketing… more
- Boehringer Ingelheim (Ridgefield, CT)
- **Description** Review promotional claims and materials for BI Rx drug promotion for compliance with Food Drug Cosmetic Act (FDCA) and for consistency with ... product labeling. Participate in Human Pharmaceutical Review Committee, providing regulatory opinion on promotional communications. Review scientific exchange communications… more
- AbbVie (North Chicago, IL)
- …Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Director Regulatory Affairs Global Regulatory Lead, Global ... approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and ensures strategic… more
- BeiGene (Emeryville, CA)
- …to negotiate with the US FDA as needed for all aspects pertaining to drug development including resolution of key regulatory issues and to expedite approvals ... **General** **Description** _:_ The Executive Director , Hematology North America Lead will be responsible...stakeholders. This individual will manage a minimum of 3 regulatory NA leaders (each who manage a group of… more
- Danaher Corporation (Raleigh, NC)
- …Regulatory Affairs department and report to the Vice President of Global Quality and Regulatory Affairs. The Director of Global Regulatory Affairs will be ... responsible for developing and executing regulatory strategies for drug development and commercialization ensuring compliance with global regulations and… more