- Catalent Pharma Solutions (San Diego, CA)
- …International cGMP regulations and experience working directly with the local and international regulatory agencies; + Must have a demonstrable record of ... Safety, Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance, and sound fiscal responsibility. Lead the development… more
- Astellas Pharma (Westborough, MA)
- …for biotechnology. Working understanding of ICH Q7, Q8, Q9, Q10, and other international regulatory requirements. + Ability to interpret regulatory rules, ... qualification and validation procedures and practices in accordance with global regulatory bodies (FDA, EMA, ICH, Japan guidance), Astellas policies and procedures… more
- Amazon (Austin, TX)
- …leadership up to the executive level on any local, state, federal, and international regulatory and compliance issues. * Leads development and implementation of ... by investigating supplier programs, establishing testing requirements in accordance with regulatory and WFM requirements, and developing and maintaining safety and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …systems for medical device and digital health technologies, ensuring compliance with international regulatory requirements and Takeda Global procedures. + Lead ... fostering talent, accountability, and high performance to advance quality, ensure regulatory readiness, and drive innovation and operational excellence and execute… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …of US Food & Drug Administration (FDA) and European Medicines Agency (EMA) regulatory requirements and International Council for Harmonisation (ICH) of Technical ... possible, together. **Job Description** As an Associate Director, Global Regulatory Affairs, you will act as the Regional ...Regulatory Affairs, you will act as the Regional Regulatory Lead on more complex or multiple products, compounds,… more
- Kemin Industries (Lenexa, KS)
- …in compliance with company and regulatory agency standards. + Support regulatory inspections and audits by USDA or international authorities. + Identify ... Research Associates - a Kemin Company is hiring a Regulatory Affairs Specialist. We're looking for someone who thrives...veterinary use. This is an excellent opportunity for a regulatory professional who is passionate about animal health and… more
- Oracle (Santa Clara, CA)
- …a plus. **Technical Expertise:** * Basic understanding of EMC fundamentals and international regulatory frameworks. * Familiarity with lab equipment, test ... international standards for Electromagnetic Compatibility (EMC) and regional regulatory requirements. The successful candidate will work closely with senior… more
- J&J Family of Companies (Santa Clara, CA)
- …+ Maintain compliance with adverse event reporting determinations against domestic and international regulatory requirements which include but are not limited to ... techniques, and standards in compliance with applicable domestic and international Medical Device Post Market Surveillance regulations. **Essential Job Functions**… more
- SpaceX (Bastrop, TX)
- …EMC standards and requirements + Familiarity with US, Canadian, EU, and other international regulatory requirements and standards + Experience with NRTL, NEC, ... most. They will oversee, build, and develop the team that drives regulatory efforts, impacts internal design decisions, and obtains the certifications necessary to… more
- Northrop Grumman (Redondo Beach, CA)
- …trade compliance records and provides reports in accordance with various regulatory requirements and international trade agreements . Oversees division ... Aeronautics Systems has an opening for a Sr. Manager International Trade Compliance (M2 level) to join our team...related discipline with a minimum of 7 years of international trade compliance experience or 5 years of related… more