VP, Regulatory Affairs

BACK TO JOBS VP, Regulatory Affairs APPLY NOW Title: VP, Regulatory Affairs Position Type: Permanent Location: Raleigh, NC Brio Resource Group is a search firm committed to providing rare pharmaceutical talent on an executive search basis to the Pharmaceutical, Biopharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging companies. Our many years of experience, subject matter expertise, proven search process and genuine passion to deliver rare talent defines Brio. Our executive search division of Brio is conducting a search for a highly-respected Regulatory Leader for one of our most innovative biopharmaceutical clients developing life-changing novel oncology immunotherapies located in RTP. This is a highly strategic, Vice President level role leading lead all regulatory activities associated with late-phase clinical development and commercialization for novel immunotherapy products in several cancer indications. We welcome the opportunity to provide a full job description upon resume review. Responsibilities: Leading overall regulatory strategy oncology immunotherapy pipeline attaining approvals Formulating the regulatory strategy of submissions to the US FDA and other health authorities Strong experience with CMC regulatory with an emphasis on biologics/ATMPs Balance business objectives with evolving regulatory requirements in the ATMP space Lead all submission activities for original INDs, IND amendments, BLAs, etc. Requirements: 15+ years of Regulatory experience Experience in pharmaceutical/biotechnology company with a proven track record in oncology drug submissions (e.g., IND, BLA, MAA) Experience with ATMP and biologics drug development MS/MA and/or Ph.D., PharmD or MD degree in a scientific discipline Ability to apply and integrate regulatory and compliance experience into business strategy Desire and passion to lead an emerging focused Biopharma therapeutically focused on novel immune-oncology and immunotherapy platforms How To Apply: Once you click “APPLY” an appropriate member of our executive recruitment team will review your credentials and respond to arrange an initial interview to review your credentials and career objectives. We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent. Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status