- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …Knowledge and understanding of FDA regulations for the biotechnology and pharmaceutical industry. Understanding of global regulatory regulations. Excellent oral ... Regulatory Affairs or related field within the Biologics, Biotech or Pharmaceutical industry. Sound basis of regulatory knowledge. Ability to write… more
- West Pharmaceutical Services (Exton, PA)
- …customers with West product compliance information and data as required for regulatory compliance and submissions to North America, Europe, and Rest of World ... **Job Summary** The Sr. Specialist, Regulatory Affairs evaluates supplier regulatory declarations for compliance , authors and maintains material … more
- Teva Pharmaceuticals (West Chester, PA)
- …or a department that works closely with RA including Quality Assurance, Regulatory Compliance , Regulatory Operations, Quality Control, Program Management, ... *Manager, Regulatory Affairs Date: May 5, 2025 Location: West...a Master's degree in the specified fields. Must have biotech/ pharmaceutical industry experience with: + GXP including cGMP practices… more
- University of Pennsylvania (Philadelphia, PA)
- …He/she will, with minimal supervision, prepare and process all required regulatory documentation for pharmaceutical companies, contract research organizations ... in study team meetings, research team meetings, and ongoing protocol training/ compliance meetings. The Regulatory Affairs Specialist-CC is expected to… more
- Sanofi Group (Swiftwater, PA)
- …compliance activities for assigned deliverables, develops, executes + regulatory submission planning activities, including generating submission content plans, ... **Job Title:** Regulatory Strategist - mRNA Vaccines **Location** : Swiftwater,...enable successful product development and market access, while ensuring compliance with evolving global regulations specific to mRNA technologies.… more
- Lilly (Philadelphia, PA)
- …through philanthropy and volunteerism. **Position Overview:** The Manager - CMC Regulatory is responsible for the preparation and delivery of high-quality CMC ... regulatory submissions. This position supports Lilly/Avid diagnostic radiopharmaceutical marketed...chemistry or related field, or PharmD + Experience in pharmaceutical development and/or manufacturing with two years of CMC… more
- Sanofi Group (Swiftwater, PA)
- …documents (such as IB, PBRER, DSUR, RMP, etc). + Supports operational and compliance activities for assigned regulatory deliverables and develops regulatory ... **Job Title:** Regulatory Strategist - Vaccines **Location** : Swiftwater, PA/...field) preferred. + At least 6 years or prior pharmaceutical /biotechnology industry experience, including at least 3 years of… more
- Lilly (Philadelphia, PA)
- …change control issuing and assessments, as well as task management to ensure compliance with quality management systems + CMC regulatory operations (eg, ... a scientific discipline + Minimum of 1 year of experience in pharmaceutical development, manufacturing, CMC regulatory , project management, and/or related field… more
- Bausch + Lomb (Harrisburg, PA)
- …global reporting, administrative documentation, due diligence, market expansion, labeling content, regulatory compliance , regulatory intelligence and change ... closely with commercial leaders to define strategy and execute registrations, provides regulatory intelligence and ensures regulatory compliance . + Provide… more
- Sumitomo Pharma (Harrisburg, PA)
- …+ Minimum 2 - 3 years of relevant experience in biotech or pharmaceutical industry specific to Pharmacovigilance operations and compliance . + Strong ... Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations...considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and… more