- University of Pennsylvania (Philadelphia, PA)
- …Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start-Up Specialist-CC to facilitate, with minimal supervision , ... the regulatory aspects of the initiation of Phase I-V clinical...any class protected under applicable federal, state or local law . Special Requirements A background check may be… more
- Sanofi Group (Swiftwater, PA)
- …possible. Ready to get started? **Main Responsibilities:** + Develop CMC regulatory strategies and assess associated risks for development projects and/or registered ... products (new products or marketed products) in collaboration with all Global Regulatory Affairs entities. + Participate in Change Control assessment. + Guarantee… more
- Compass Group, North America (Wayne, PA)
- …VP of Operational Strategy by leading all efforts related to regulatory compliance, policy standardization, survey readiness, and infection prevention alignment ... that all Crothall operations meet internal standards and external regulatory requirements, maintains accessible and up-to-date documentation, and positions Crothall… more
- Organon & Co. (Plymouth Meeting, PA)
- …labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and most of ... labeling documents for company products, including Core, US and supporting country regulatory affiliates for consistency of labeling documents around the world. +… more
- Pfizer (Collegeville, PA)
- …practices; drive relentless digital innovation; ensure unwavering compliance with global regulatory standards; and act as a trusted strategic advisor to the ... new science data, shifts in public opinion, and evolving regulatory landscapes to modify and refine the Pfizer global...a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if… more
- Williams Companies (Pittsburgh, PA)
- …status, genetic information or any other basis protected under applicable discrimination law . Do something that means something at Williams. This isn't just a ... bring your energy to ours! The State Government & Regulatory Affairs Rep Sr. is responsible for leading, developing...relations or related field + Preferred: Master's degrees in Law , Business, Political Science, Communications; a minimum of eight… more
- Sumitomo Pharma (Harrisburg, PA)
- …Investigator Brochures (IBs), informed consent forms (ICFs), protocols, study reports, regulatory reports, and regulatory responses. + Contribute to signal ... benefit-risk assessment. + Collaborate with colleagues in Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and other departments. Represent… more
- Penn Medicine (Philadelphia, PA)
- …The SCD also partners with each entity to ensure departmental compliance with Regulatory and Infection Prevention Guidelines The SCD will serve as a leader in ... education and skill validation of clinical staff. Quality, Patient Safety, and Regulatory Affairs: Partnership with the Vice Chair for Quality, Medical Director of… more
- Prime Therapeutics (Harrisburg, PA)
- …responsible for the successful development, implementation and execution of the Regulatory Intelligence communication strategy. This position acts as Compliance and ... regulatory liaison for all lines of business with internal...other legally protected class under federal, state, or local law . _ _We welcome people of different backgrounds, experiences,… more
- University of Pennsylvania (Philadelphia, PA)
- …This position requires significant dedication and resilience to acquire and apply regulatory knowledge with the duty to protect research patient safety and data ... understanding of roles and responsibilities of investigators, sponsors, CROs, and regulatory bodies including specific role of IRBs. After completing institutional… more