- AbbVie (Mettawa, IL)
- …Tok (https://www.tiktok.com/@abbvie) . Job Description The Senior Manager Regulatory Affairs US Advertising and Promotion Immunology-Dermatology combines knowledge ... of scientific, regulatory and business issues to enable products that are...skills across therapeutic areas. + Ensure departmental training and compliance with established regulations, guidance, promotional guidelines and SOPs… more
- J&J Family of Companies (Titusville, NJ)
- …needs with initial focus on the key markets identified. + Ensure business compliance , and implementation of and adherence to regulatory standards. + Serve ... and contribute to the development of local labels as appropriate. Provide regulatory input to clinical development programs, risk/benefit assessments, medical… more
- Stryker (Redmond, WA)
- …regulatory issues. + Provide strategic guidance and implementation plans for compliance with evolving regulatory requirements. + Establish standard process to ... experience. + Previous experience in a technical function (ie Engineering, Quality, Clinical , Pre or Post Market Regulatory , Manufacturing). **Preferred** : +… more
- Candela Corporation (Marlborough, MA)
- …operating goals. + Global accountability for establishment and maintenance of required Regulatory Compliance elements, QS certifications (ie, MDR, MDSAP, etc.), ... **Director, Global Regulatory Affairs** Requisition Number **2872** Location **US -...worldwide and are supported by capital sales, field service, clinical education, technical support and marketing development organizations. Candela… more
- Bristol Myers Squibb (Indianapolis, IN)
- …(eg, IND, IMPD, NDA, and MAA) for submission to global Health Authorities in compliance with departmental and regulatory standards + Work with the Indianapolis ... radiopharmaceuticals . We are seeking an experienced and motivated **Senior Director, Regulatory Affairs - CMC (Manufacturing)** . This position will report to the… more
- System One (Florham Park, NJ)
- Job Title: AD or Director, Regulatory Affairs Strategy Location: Florham Park, NJ (10 days onsite per month) Type: 12-month contract Must haves: + Must be local for ... fully remote is NOT an option. + Must have regulatory strategy experience in IND/NDA development, not just life...+ Preparation of Type C/B/D Meetings for antivirals in clinical development (as needed) + Contributions to and finalization… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …and become your best self. Become a **maker of possible** with us. The Regulatory Affairs (RA) Director is responsible for the management and setting the direction ... Business Unit. The RA Director is responsible for developing and implementing regulatory strategies and submissions in support of global marketing within the MDVC… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Regeneron Genetics Center, Regeneron Cellular Medicine, the Oncology and Hematology Clinical Development Units on regulatory strategies for the development ... The role leads a group within Regeneron's Regulatory Affairs organization that provides guidance to Research,...are met within specified timelines and vital state of compliance is maintained. In addition, the position acts as… more
- Abbott (St. Paul, MN)
- …of blocked sales and distribution orders, providing guidance and direction on regulatory compliance . . Reviews and evaluates customer service requests and ... accuracy, clinical and distribution, supply planning support and overall regulatory operations activities. . Have a full working knowledge of product release… more
- Takeda Pharmaceuticals (Boston, MA)
- …and works effectively with a Global Regulatory Team to develop the regulatory framework for the clinical development of small molecules and biologic products ... to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs, Neuroscience is responsible for developing innovative global … more