- Sumitomo Pharma (Harrisburg, PA)
- …a dynamic, highly motivated, and experienced individual for the position of **Associate Director , Regulatory Affairs (Oncology).** The Associate Director ... is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will...support the successful submission and achievement of target product labeling + Responsible for creating and reviewing SOPs and… more
- The Hershey Company (Hershey, PA)
- …location is Hershey or east coast with travel to Hershey monthly.* * Overview* The Director of Regulatory Affairs for the Americas is responsible to assure ... including but, not limited to auditing and monitoring, and regulatory approval processes. The Director will proactively...issues impactful to the business. 3. Lead the cross-functional Regulatory & Scientific Affairs team to continuously… more
- CSL Behring (King Of Prussia, PA)
- As the Senior Director , Medical Affairs , you will lead the development and execution of Medical Affairs strategies and tactics to support the assigned US ... + Review and approve medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs...the assigned disease area. + Provide input on US labeling and regulatory strategy. + Maintain in-depth… more
- Merck (North Wales, PA)
- **Job Description** The Associate Director , Regulatory Affairs , supports products in the Oncology therapeutic area as part of a regulatory team. The ... science and strong communication and analytical skills. Our Regulatory Affairs team bring new medical advancements... regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling , Regulatory… more
- CSL Behring (King Of Prussia, PA)
- …**Qualifications & Experience Requirements** Bachelor's degree required. *8+ years of Regulatory Affairs experience, with at least 6+ years specifically ... days a week. You will report to the Executive Director , Head, Global Labeling & Labeling...and Promotion is responsible for developing and overseeing the regulatory strategy and compliance of promotional and non-promotional with… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional colleagues in preclinical science, data science, clinical operations, regulatory affairs , chemistry, manufacturing and control (CMC), project ... **Job Description** **The** **Position** The Director , Clinical Pharmacology Lead will be responsible for...to the authoring of modules 2.7.3, 2.7.4, 2.5 and labeling for regulatory submissions, contribute the authoring… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs , Research & Development, Legal, and Health ... lifecycle for all Olympus therapeutic areas. You will report directly to the Senior Director Medical Safety as a member of the global medical safety team. You must… more
- University of Pennsylvania (Philadelphia, PA)
- …visits and any necessary testing; Preparing for study visits including labeling and creating visit packets; Collecting and reviewing study data; Processing ... and shipping study biospecimens; Escorting patients to research visits; Assisting with regulatory activities such as IRB submissions, maintenance of site files and… more