- J&J Family of Companies (Titusville, NJ)
- …as a single submission. Johnson & Johnson Innovative Medicine R&D is recruiting for a Director , Global Regulatory Leader. This position is a hybrid role and can ... Titusville, NJ; Raritan, NJ; or Spring House, PA. The Director , Global Regulatory Leader will be responsible...is required. + A broad understanding and experience in drug development, including early and late development is required.… more
- Stryker (Flower Mound, TX)
- The ** Director , Regulatory Operations** leads regulatory compliance for the **Endoscopy Division** and provides strategic leadership to cross-functional ... ensuring timely market access for products in alignment with applicable regulations. The Director will be responsible for roughly 5 direct reports and a total team… more
- Takeda Pharmaceuticals (Boston, MA)
- …related experience. + Experience in reviewing, authoring, or managing components of regulatory submissions. + Expert knowledge of drug development process and ... + Defines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple… more
- Stryker (Tempe, AZ)
- The ** Director , Regulatory Affairs** is a key strategist, responsible for developing and executing the global regulatory strategy for **Stryker ... providing reprocessing and remanufacturing solutions to our customers globally. The Director will partner closely with business unit leadership and respective… more
- Lilly (Indianapolis, IN)
- …make life better for people around the world. Eli Lilly and Company seeks a Regulatory Affairs Director (R7-R8) to support the execution of regulatory ... a minimum of: 5 years of experience with preparing Food and Drug Administration regulatory submissions; 5 years of experience with drafting Investigational New … more
- Lilly (Indianapolis, IN)
- …new medicines to patients who need them all over the world. The Senior Advisor/ Director Post approval scientist in Global Regulatory Affairs - CMC commercial ... molecule drug products, or equivalent combination of technical and regulatory guidance knowledge. + Knowledge of major market procedures, regulations, and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …leader in radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director , Regulatory Affairs - CMC (Manufacturing)** . This position will ... report to the Head of Regulatory Affairs and will oversee and/or manage CMC ...leading to successful preparation and approval of Investigational New Drug applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), … more
- Sumitomo Pharma (Madison, WI)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Director , Regulatory Advertising & Promotion** . The Director is ... in the US. He/she will primarily function as the Regulatory reviewer for assigned products. This position is responsible...Establish a working relationship with the Office of Prescription Drug Promotion (OPDP) at FDA. + Serve as internal… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for ... regulatory nuances and requirements. + Understanding of scientific principles and regulatory /quality systems relevant to drug development. + Ability to… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** As Associate Director , Regulatory Affairs, you will be responsible for leading RA team members involved in device project activities ... within the pharmaceutical or medical device industries, ideally with expertise in drug -device combination products; experience in regulatory and/or R&D, quality… more