- Mentor Technical Group (Juncos, PR)
- …device safety and efficacy guidelines. With offices in Caguas, Puerto Rico and Boston, United States , we serve life sciences clients in six global markets: ... comprehensive portfolio of technical support and solutions for the FDA regulated industry. As a world leader in life...United States , Puerto Rico, Dominican Republic, Mexico,… more
- Ascendis Pharma (Palo Alto, CA)
- …fast-growing global biopharmaceutical company with locations in Denmark, Europe, and the United States . Today, we're advancing programs in Endocrinology Rare ... of absence. The ICSR Management Lead reports to the Head , ICSR Management within the Global Patient Safety (GPS)...+ Supports with the oversight of regulatory and departmental compliance by ensuring timely processing of ICSRs in the… more
- Lilly (San Diego, CA)
- …as well as regulatory strategy development + Monitor patient safety and ensure compliance with GCP, FDA , ICH guidelines, and company policies **Cross-Functional ... Medical Affairs Support** + Partner with regulatory colleagues on IND strategy, FDA interactions, and global development planning + Contribute medical expertise to… more
- ITG Brands (NC)
- …and nicotine products. The ideal candidate will bring deep expertise in FDA regulation, multi-state compliance , and regulatory litigation, with the ability ... industry (tobacco, pharmaceuticals, medical devices). + Strong background in FDA regulatory matters, state-regulatory compliance , regulatory litigation, FOIA.… more
- Mallinckrodt Pharmaceuticals (St. Louis, MO)
- …of manufacturing sites in the area of Quality Systems, and Training. + Interfaces with FDA and regulatory agencies outsite the US for events that include but are ... The Sr. Director, Quality is responsible for ensuring cGMP compliance and product quality at the Saint Louis, MO...results from direct and indirect reports. + Knowledge of FDA and International regulations and guidances in the area… more
- West Pharmaceutical Services (Williamsport, PA)
- …of queries / product launches. + Have in-depth / working knowledge of: ISO 13485, US FDA 21 CFR Part 820, ISO14971 + Have strong self-motivation, the ability ... processes related to the manufacture of West products. Ensure compliance with regulatory requirements and West procedures. Proactively develop,...US and other regional/ country legislation, act as Head of Quality Control/ Head of Quality/… more
- Bristol Myers Squibb (Indianapolis, IN)
- **Working with Us ** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is ... at work and in their personal lives. Read more: careers.bms.com/working-with- us . RayzeBio, a Bristol Myers Squibb company, is...radiopharmaceutical production. The candidate will work closely with the Head of Program Management, the Head of… more
- CSL Behring (King Of Prussia, PA)
- …Support the development and maintenance of PV systems and processes in compliance with international standards (ICH, EMA, FDA ). * **Cross-functional ... three days a week. You will report to the Head of Global Regulatory Science and Policy. **Position Description**...affairs, and quality assurance teams to ensure alignment on compliance and safety strategies. Participate in internal audits and… more
- Mentor Technical Group (Juncos, PR)
- …San Francisco, CA and we serve life sciences clients in six global markets: United States , Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South ... provides a comprehensive portfolio of technical support and solutions for the FDA -regulated industry. As a world leader in life science engineering and technical… more
- Takeda Pharmaceuticals (Los Angeles, CA)
- …+ Maintain applicable QC Microbiology Standard Operating Procedures (SOP) to ensure compliance with FDA guidelines, QSR, cGMP, and other regulatory standards ... and drive procedural improvements. + Support internal and external audits (eg, FDA , Corporate Quality Assessments) by ensuring compliance with procedures,… more