- Ascendis Pharma (Princeton, NJ)
- The Regulatory Affairs (RA) Associate Director , Labeling will be responsible for labeling activities across programs and stages of development, with ... Americas and supporting global needs as required. The RA Associate Director , Labeling will be...for regulatory submissions and product maintenance. The Associate Director prioritizes their own work to… more
- Takeda Pharmaceuticals (Columbus, OH)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... of labeling documentation and assures that Takeda labeling content and processes conform to regulatory ...Takeda labeling content and processes conform to regulatory requirements. Management of Local Exceptions and LOC Interactions… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Global Labeling Product Leader (1 of 2) - 2406187352W **Description** Johnson & Johnson Innovative Medicine is recruiting for an ... Associate Director Global Labeling Product...Information, Pharmacovigilance) including at least 6 years of direct regulatory labeling content experience developing and writing… more
- Takeda Pharmaceuticals (Columbus, OH)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director , Global Labeling Lead where you will be ... and/or related experience. + Knowledge of US and EU product labeling regulatory requirements and guidelines. + Familiarity with US and/or EU regulatory… more
- Bausch Health (Bridgewater, NJ)
- …your skills and values drive our collective progress and impact. The Associate Director , Advertising and Promotion, Prescription Drug Products, reviews, approves ... and monitors prescription drug product advertising and promotional labeling pieces for compliance with regulatory agency requirements. Responsibilities **:** +… more
- J&J Family of Companies (Cincinnati, OH)
- Associate Director , Regulatory Affairs (Instruments & Accessories) - Robotics & Digital Solutions, Inc. - 2406195848W **Description** Robotics & Digital ... part of the Johnson & Johnson family of companies, is recruiting for an ** Associate Director , Regulatory Affairs** to support our Instruments and Accessories… more
- Sanofi Group (Bridgewater, NJ)
- **Job title: Associate Director , US Advertising and Promotion, Global Regulatory Affairs** + Location: Cambridge, MA or Bridgewater, NJ **About the job** The ... Associate Director , US Advertising and Promotion serves...leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising… more
- Abbott (Alameda, CA)
- …work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Associate Director Regulatory Affairs - APAC** will work ... Diabetes Division. As a manager, the function of an Associate Director Regulatory Affairs, APAC...preclinical, clinical and manufacturing charges. + Review and approve labeling to ensure compliance. + Represent regulatory … more
- Novo Nordisk (Princeton, NJ)
- …lives for a living. Are you ready to make a difference? The Position The Associate Director , Regulatory Affairs - Advertising & Promotion will provide ... strong and positive working relationship with OPDP reviewers. Report to Senior Director , Regulatory Affairs - Advertising & Promotion. Essential Functions +… more
- BD (Becton, Dickinson and Company) (Covington, GA)
- **Job Description Summary** As Associate Director , Regulatory Affairs, you will be responsible for managing a team that develops and executes the strategy ... and timelines for submission of various regulatory licensing activities for new and currently marketed products. **Job Description** We are **the makers of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and operational regulatory guidance on new concepts, campaigns, and product labeling for the assigned brands. You may manage complex interactions related to ... Project Team meetings. + Represents RA Ad/Promo at labeling meetings and provides strategic regulatory guidance....Ad/Promo at labeling meetings and provides strategic regulatory guidance. + Mentors RA Ad/Promo and cross-functional team… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Responsibilities** + Ensure global regulatory plans support a precision medicine approach eg integrated drug/diagnostic ... regulatory and submission plans), including HA engagement plans and...study reports, IBs, INDs, CTAs, IDEs, SRDs, PMAs and labeling for drug and diagnostic products. Provides guidance on… more
- BD (Becton, Dickinson and Company) (Milpitas, CA)
- …development and execution of regulatory submissions. + Serves as a regulatory expert for labeling and promotional materials review, experimental designs, and ... with us. **Key responsibilities will include:** + Responsible for the global regulatory strategy for BDB products. + Coordinates and advises the preparation of… more
- Organon & Co. (Plymouth Meeting, PA)
- …of the Promotion Review Committee. + Providing day-to-day legal advice to the labeling , quality, supply chain, and regulatory organizations in R&D and ... support and counseling to business clients on a wide range of FDA regulatory and compliance issues (including GxP compliance) for the commercial, research &… more
- Bristol Myers Squibb (Princeton, NJ)
- …careers.bms.com/working-with-us . **Position Responsibilities** + Develop global and/or US regulatory strategy for Oncology products in development and through life ... + Develop strategic direction and provide leadership for all regulatory interactions with FDA/global regulatory authorities +...+ Provide strategic direction (and content input) on US Labeling + Anticipate and interpret key trends and changes… more
- Teva Pharmaceuticals (West Chester, PA)
- …registration. This position comes with 4 direct reports (Dir, Sr Manager, Manager & Associate III). The Sr Director , Regulatory Affairs CMC is responsible ... process development, device development, analytical methods, formulation development, manufacturing, and labeling . The Sr Director , Regulatory Affairs CMC… more
- BeiGene (Emeryville, CA)
- **General Description:** _The Associate Director , Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages ... in departmental activities **Supervisory Responsibilities:** This position has no direct reports. The Associate Director , Safety Scientist is part of a team that… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Friday, June 28, 2024 Looking for a chance to make a meaningful difference in ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the...Investigator Brochures, clinical summary of the NDA/MAA and product labeling and other applicable documents for clinical trials. +… more
- Bristol Myers Squibb (Princeton, NJ)
- … of US Medical Oncology, Genitourinary (GU). The primary responsibility of this Associate Director is conducting strategic review of promotional materials and ... and objectives with the GU tumor portfolio. As a promotional review lead, this Associate Director role is a strategic partner who is solution oriented and… more
- ThermoFisher Scientific (Wilmington, NC)
- …trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor ... ( eg PBRER, PSUR, DSUR) as well as other client deliverables (eg labeling reconciliation documents, CTD modules, REMS, RMP and CSR). **Essential Functions:** Manages… more
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