- University of Pennsylvania (Philadelphia, PA)
- …wealth 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 ...Penn), regulatory bodies (both internal and external) and research participants. Regulatory Affairs staff… more
- University of Pennsylvania (Philadelphia, PA)
- …as the primary point of authority for the Physician-Investigators and clinical research staff on regulatory affairs matters. The Associate Director for ... Director, Regulatory Job Profile Title Associate Director, Clinical Research Regulatory Job Description...the Director, the Associate Director for Regulatory Affairs will oversee the portfolio of clinical … more
- Cardinal Health (Harrisburg, PA)
- …as well as clinical research and manufacturing process consulting. Regulatory Affairs plans, coordinates and implement regulatory strategies for ... **_What Regulatory Affairs contributes to Cardinal Health_**...the integrity of regulatory data used for regulatory submissions, clinical evaluations and post-market surveillance.… more
- CSL Behring (King Of Prussia, PA)
- …active inputs from key stakeholders in medical affairs , sales, commercial development, clinical research and development, regulatory affairs , etc. ... Operations input is provided in the development of Target Product Profiles, clinical research protocols and Target Labeling copy through appropriate channels… more
- Sumitomo Pharma (Harrisburg, PA)
- …+ Provide strategic and operational leadership to the Marketing Brand Teams, Legal, Medical Affairs and Clinical Research in the development of advertising ... and experienced leader for the position of **Vice President, Regulatory Affairs Oncology** . The candidate must...individual will be responsible for leading development of all non- clinical and clinical regulatory strategies… more
- West Pharmaceutical Services (Exton, PA)
- Director, Regulatory Affairs Requisition ID: 71273 Date: Oct 8, 2025 Location: Exton, Pennsylvania, US Department: Regulatory Affairs Description: ... and planet through our sustainability efforts. **Job Summary** The Director of Regulatory Affairs provides strategic leadership and project management to ensure… 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...terminology, and FDA and ICH regulations/guidance documents specific to clinical research and general product development in… 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...medical terminology, and FDA and ICH regulations/guidances specific to clinical research and general product development in… more
- Sumitomo Pharma (Harrisburg, PA)
- …highly motivated, and experienced individual for the position of Vice President, Regulatory Affairs , Biopharma R&D. This position leads the Regulatory ... CNS assets. **Job Duties and Responsibilities** **_Regulatory Strategy_** + Develop and Manage Regulatory Affairs Strategy + Develop and gain approval for … more
- West Pharmaceutical Services (Exton, PA)
- Sr. Specialist, Regulatory Affairs , Product Stewardship Requisition ID: 69466 Date: Oct 10, 2025 Location: Exton, Pennsylvania, US Department: Regulatory ... and planet through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs evaluates supplier regulatory declarations for… 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
- Penn Medicine (Philadelphia, PA)
- …PA + Hours: 8hr Days **Summary** : The Senior Corporate Director of Regulatory Affairs for Penn Medicine provides leadership and strategic direction across ... Management and Leadership: Manage and provide leadership to all entity directors of regulatory affairs , ensuring alignment with Penn Medicine goals and … more
- Bausch + Lomb (Harrisburg, PA)
- …Bachelor degree or equivalent, Master degree preferred + Minimum of 8 years in Regulatory Affairs or relevant experience in a regulated environment + Ability to ... + Strong business acumen and ability to see the business drivers outside of Regulatory Affairs + Ability to take innovative ideas to promote a successful… 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
- Organon & Co. (Plymouth Meeting, PA)
- …questions per established business processes and systems. + Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... project timelines. **Preferred Experience and Skills** A candidate with experience in Regulatory CMC in clinical development, initial marketing application and… more
- University of Pennsylvania (Philadelphia, PA)
- …participate in the coordination of Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the Regulatory Affairs ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist B...cutting-edge oncology treatments. Contingent upon funding. The ACC OCCR Regulatory Affairs Office seeks a full-time … more
- Edwards Lifesciences (Allentown, PA)
- …up. **How you'll make an impact:** + As a key member of the Medical Affairs Clinical Science team, the Senior Manager (formal internal title is Senior Manager, ... lives. This is an exciting opportunity for an exceptional Clinical Scientist professional to join a team that is...Medical Affairs ) is responsible for providing scientific expertise throughout the… more
- Veterans Affairs, Veterans Health Administration (Philadelphia, PA)
- …and database software. Screens, recruits, and assesses potential participants for research or clinical demonstration eligibility; reviews medical charts and ... designs, protocols, and data collection method; (2) ensuring compliance with research protocols, ethical standards, and regulatory guidelines. OR, Education:… more
- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …moderate and/or high complexity testing (as categorized by the FDA) in a clinical laboratory. Research laboratory experience does not fulfill this requirement. ... fluids (or categorical experience that matches categorical certification) in a clinical laboratory. Research laboratory experience does not fulfill this… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …(T0 - T1) or early development (phase 1) assets either within Medical Affairs , Regulatory Affairs , or Clinical Development is preferred. + Minimum of 7+ ... this role. + Stay abreast of the latest advancements, research , and publications within the assigned disease areas in...evidence, US and global commercial teams, market access, and regulatory affairs , to ensure integrated global strategies… more