- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Regulatory Affairs Specialist Job Profile Title Clinical ... Research Regulatory Specialist B Job Description Summary Regulatory Affairs as a field is concerned...in obtaining and maintaining institutional and governmental approval for clinical trials. These trials often include FDA -regulated… more
- Sumitomo Pharma (Harrisburg, PA)
- …dynamic, highly motivated, and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must be deeply experienced ... individual will be responsible for leading development of all non- clinical and clinical regulatory strategies...to VP Clin Dev and CMO + Manage Commercial Regulatory Affairs function and serve as an… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs , is responsible for preparing, filing and gaining approval ... labeling in terms of indications and reimbursement. + Works with Product Development, Clinical Affairs , Quality, Management and other areas of the organization… more
- Sumitomo Pharma (Harrisburg, PA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of **Director Regulatory Affairs ** . The Director is part of the Global ... Regulatory Affairs (GRA) team based in the...Regulatory Affairs (GRA) team based in the US. He/she will... templates + Advanced understanding of medical terminology, and FDA and ICH regulations/guidances specific to clinical … more
- Sumitomo Pharma (Harrisburg, PA)
- …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...to achieve results + Understanding of medical terminology, and FDA and ICH regulations/guidance documents specific to clinical… more
- West Pharmaceutical Services (Exton, PA)
- Senior Regulatory Affairs Specialist Requisition ID: 71673 Date: Oct 6, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs ... and planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs , Medical is responsible for influencing department … more
- Parexel (Harrisburg, PA)
- …for NCEs and biologics * Deep knowledge of FDA , ICH, and global regulatory frameworks * Experience with international clinical trials and regulatory ... **Join Parexel as a Regulatory Affairs Strategy Lead** Are you...programs from early development through approval * Coordinate cross-functional regulatory activities (CMC, nonclinical, clinical ) to meet… more
- Parexel (Harrisburg, PA)
- …and approved programs, helping to shape the future of life-saving therapies. As a **CMC Regulatory Affairs Senior Associate** , you will play a critical role in ... discipline (advanced degree preferred). + 4+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry. + Proven… more
- Bausch + Lomb (Harrisburg, PA)
- …degree or equivalent; Master's degree preferred + Minimum of 8 years in Regulatory Affairs with experience in the consumer product (Rx/OTC, OTC Monograph, ... US and/or Canada + Formulate, lead, and drive integrated regulatory strategies across CMC and clinical /non- clinical...and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …experience or Master's degree with 2 years' experience in regulatory affairs or related areas (eg, clinical development, project management, quality ... **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription… more