- Takeda Pharmaceuticals (Boston, MA)
- …or a related specialty, disease mechanisms and plasma derived/related therapies + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in plasma ... empower you to shine? Join us as a Medical Director , Clinical Sciences - Plasma Derived Therapies in our...realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation,… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- … submission content (510(k), Technical Files, etc.) + Develop and implement global regulatory strategy for MMS Dispensing Medical Device and non-Medical ... self. Become a maker of _possible_ with us. The Director of Regulatory Affairs reports directly to...PowerPoint, Teams + Project Management experience + Knowledge of global Regulatory Affairs requirements, regulations and standards… more
- Gilead Sciences, Inc. (Frederick, MD)
- …auditors, providing mentorship, performance evaluations, and long-term career development. The Director ensures compliance with global regulatory ... Director for a GxP Auditing role. The Director of GxP Auditing will lead Kite's global...Define and execute a comprehensive audit strategy aligned with global regulatory expectations (FDA, EMA, MHRA, PMDA,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Therapeutic area knowledge + Pulmonologist/Neurologist with sleep medicine expertise + Regional/ global Regulatory requirements + GCP/ICH + Emerging research in ... Medical Director leads and drives strategy for the overall global (US/EU/Japan/China) clinical development taking into consideration the medical, scientific, … more
- Takeda Pharmaceuticals (Cambridge, MA)
- …+ Therapeutic area knowledge relevant to mechanism of action + Regional/ global Regulatory requirements + Emerging research in designated therapeutic ... Medical Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical, scientific, … more
- Amgen (Cambridge, MA)
- …and implement strategy for commercial drug product programs, life-cycle management, global regulatory submissions, and variation management for biologics, ... key messages relative to diverse audience requirements + Knowledge of applicable global regulatory requirements. Experience preparing technical sections of … more
- Boehringer Ingelheim (Ridgefield, CT)
- …Product Labeling Review Team (PLRT) and in collaboration with US RA Labeling Content, provide CMC regulatory support during Annual, CCDS, or ad-hoc product ... Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require the Fellow to develop… more
- Sysco (Rahway, NJ)
- …regulatory requirements in domestic and international markets. + Stay current on global regulatory trends; assess potential impact and ensure timely alignment ... building a high-performing quality culture across the organization. **POSITION PURPOSE:** The Director of Global Quality Assurance & Quality Control leads the… more
- J&J Family of Companies (Titusville, NJ)
- …clinical study reports and for the preparation and approval of essential documents for global regulatory filings. The CL will manage direct reports who are ... matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs, finance, legal, quality assurance, quality… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- …typically carrying out the responsibilities with minimal guidance from the Regulatory Affairs, Advertising and Promotion Director . The Senior Manager ... typical day might include:** + Management of US and Global (if applicable) regulatory activities associated with...advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director . +… more