- Unknown (Lebanon, PA)
- Vice President of Regulatory and Clinical Affairs About the Company Pioneering organization in the oncology industry Industry Hospital & Health Care Type ... Company is in search of a Vice President of Regulatory and Clinical Affairs to...approval efforts, including the creation and submission of various regulatory documents to authorities such as the FDA… more
- Unknown (Cranbury, NJ)
- Senior Vice President, Regulatory Affairs About the Company Innovative clinical -stage biotechnology firm developing gene therapies Industry Biotechnology ... The Company is seeking a Senior Vice President for Regulatory Affairs to join their dynamic team....well as a significant level of interaction with the FDA , EMA, and other regulatory agencies, is… more
- Unknown (Fort Worth, TX)
- Vice President, Regulatory Affairs , Oncology About the Company Globally-recognized pharmaceutical company Industry Pharmaceuticals Type Privately Held Founded ... Role The Company is seeking a Vice President for Regulatory Affairs in Oncology. The successful candidate...with a focus on leading the development of all non- clinical and clinical regulatory strategies.… more
- Unknown (Boston, MA)
- …field of oncology. The Vice President will be responsible for all aspects of regulatory affairs , including global strategy, CMC, operations, and management of ... This role is pivotal in developing and driving the regulatory strategy for the company's clinical and...have a proven track record of successful interactions with regulatory agencies, a solid knowledge of FDA ,… more
- Unknown (Raleigh, NC)
- … clinical trials, serving as the primary medical interface with the FDA , and defining clinical endpoints, safety strategy, and benefit-risk positioning in ... alignment with regulatory and commercial objectives. This role also involves building...a proven track record of hands-on leadership in late-stage clinical programs leading to FDA approval. Deep… more
- Georgetown Univerisity (Washington, DC)
- …science, or related field + Minimum of 2 years of experience in regulatory affairs or clinical research + FDA , ICH-GCP) Familiarity with regulatory ... regulatory compliance and oversight of a portfolio of clinical trials overseen by the Clinical Research...the Director of the CRO, the CRC will manage regulatory for complex clinical trials across multiple… more
- Evident Scientific (Needham, MA)
- Sr. Mgr., Regulatory Affairs (RA) & Clinical Affairs (Evident MIS) Job ID #: 2215 Company: Evident Posting Date: Dec 24, 2025 Are you looking for a ... day. **Let's inspire healthier lives, together.** This role bridges Clinical Affairs and US Regulatory ...Compliance, leading end-to-end clinical programs and ensuring regulatory alignment with FDA and global standards.… more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Regulatory Affairs Specialist-CC Job Profile Title Clinical Research Regulatory Specialist ... Phase I-V clinical trials. Reporting to the Regulatory Affairs Research Teams Manager, the ...FDA , as well as organize and maintain all regulatory affairs documentation/files as required. The … more
- Sumitomo Pharma (Montgomery, AL)
- …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
- Children's Hospital Los Angeles (Los Angeles, CA)
- …rewarding. **It's Work That Matters.** **Overview** **Purpose Statement/Position Summary:** The Manager, Clinical Research Regulatory Affairs is tasked with ... personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments...oversight and governance of Regulatory Affairs department and involved in the day-to-day support of… more
- University of Pennsylvania (Philadelphia, PA)
- …programs and resources, and much more. Posted Job Title Regulatory Affairs Start-Up Specialist Senior-CC Job Profile Title Clinical Research Regulatory ... regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory...FDA , as well as organize and maintain all regulatory affairs documentation/files as required. The Senior… more
- PCI Pharma Services (Philadelphia, PA)
- …across our global network to pioneer and shape the future of PCI. The Clinical Regulatory Affairs Specialist-2 oversees the company's policies and objectives ... matters of government and regulations, with respect to the FDA , DEA, MHRA, EEU, State of Illinois, and other...and applied by all appropriate personnel. + Assists the Regulatory Affairs Manager by hosting audits, developing… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- **Overview** The Vice President of Regulatory Affairs will serve as the senior-most regulatory leader responsible for envisioning, developing, and executing ... the company's global regulatory strategy to support clinical development, product...Team Leadership * Lead, mentor, and retain a high-performing Regulatory Affairs team, including Regulatory … more
- Bristol Myers Squibb (Madison, NJ)
- …their personal lives. Read more: careers.bms.com/working-with-us . **Associate Director Commercial Regulatory Affairs ** **Description** : The role of Associate ... Director of US Commercial Regulatory Affairs requires the ability to apply...FDA regulations and guidances. **Responsibilities include:** + Provides regulatory advice, risk assessment and mitigation strategies to Commercial… more
- Kelly Services (Norcross, GA)
- …to offer a direct hire opportunity in the Norcross, GA area for a Principal, Regulatory Affairs (Transfusion).** Principal, Regulatory Affairs - IVD / ... the Role** We are seeking a highly skilled Principal, Regulatory Affairs professional to manage pre-market ...in vitro diagnostics (IVDs). The role will support global regulatory compliance across US FDA , Health Canada,… 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
- Medtronic (Minneapolis, MN)
- …a more connected, compassionate world. **A Day in the Life** **SENIOR REGULATORY AFFAIRS SPECIALIST** In collaboration with leading clinicians, researchers, and ... provide. Therefore, we are looking for a passionate **Senior Regulatory Affairs Specialist** who has direct experience...resolve potential regulatory issues and questions from regulatory agencies. + Prepare FDA , European, and… more
- Chiesi (Cary, NC)
- …environment. The internship provides a strong foundation for a future career in regulatory affairs , clinical development, or related functions within the ... We would prefer for you to have + Coursework or prior exposure to regulatory affairs , FDA regulations, or drug development. + Familiarity with… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …to bring life-changing therapies to patients worldwide. The Associate Director, Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review Lead is ... medicine promotion. **How you will contribute:** + As our Associate Director, Global Regulatory Affairs Advertising and Promotion lead you will act as the… more
- GRAIL (Dover, DE)
- …**Required Qualifications:** + MS or PhD with 10+ years of experience in regulatory , development, clinical affairs , quality, or program management within ... Affairs Certification (RAC) preferred. + Experience in pharmaceutical clinical , statistical, or regulatory settings-especially in oncology, immunology, or… more
