- PNC (Pittsburgh, PA)
- …reports on quantitative models/tools for internal/external communications and/or regulatory compliance, using applicable templates. 2. Stakeholder Collaboration and ... clearly and concisely to both technical and non-technical audiences, including regulatory staff members. Collaborate within the Model Risk Management team to… more
- Sumitomo Pharma (Harrisburg, PA)
- …Team. + Collaborate with the process and analytical development, quality, and regulatory functions to establish a robust, compliant clinical supply chain to support ... company objectives. + Champion regulatory and technical documents for regulatory submissions...domestically and international if/when needed. **Education and Experience** + PhD or MS Chemistry, Biology, or related field is… more
- Merck (West Point, PA)
- …vaccine bioanalytical outsourcing, ensuring alignment with corporate objectives and regulatory requirements. The Senior Director will oversee a multidisciplinary ... teams, including research and development, regulated bioanalytical, clinical research, regulatory affairs, and quality assurance, to provide scientific leadership… more
- Merck (North Wales, PA)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... to designing and analyzing clinical trials in support of worldwide regulatory submissions. This position involves interaction with Medical, Data Coordination,… 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
- Pfizer (Collegeville, PA)
- …manuscripts through co-authorship. The candidate may also provide support in regulatory submissions including responses to regulatory queries. Successful ... Provide scientifically rigorous statistical input into project development plans, regulatory submissions, interpretation of statistical results, study design, statistical… more
- J&J Family of Companies (Malvern, PA)
- …for:** + Oversee viral safety and viral clearance studies for investigations and regulatory requests for Cell & Gene Therapy programs and Biologics. + Design and ... reports. + Provide Virology expertise to address health authority queries and regulatory filings. + Partner effectively with stakeholders & partners for API related… more
- Merck (West Point, PA)
- …in alignment with the company's business goals, and quality and regulatory compliance. **Essential Duties and Responsibilities:** + Utilize extensive experience in ... in both development and lifecycle management, ensuring compliance with relevant regulatory standards. + Ensure robust technical plans, risk communication, drive… more
- Merck (West Point, PA)
- …in alignment with the company's business goals, and quality and regulatory compliance. **Essential Duties and Responsibilities:** _Strategic Leadership and Project ... collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality. + Provide Voice of Manufacturing input to early… more
- Pfizer (Collegeville, PA)
- …result interpretation, and providing statistical support and leadership in global regulatory submission activities, as well as implementing new initiatives and ... analysis plans, interpretation of statistical results, project development plans, regulatory issues and scientific and registration projects. + Provide planning… more