Vice President, Regulatory Affairs

Vice President, Regulatory AffairsAbout the CompanyThriving T-cell receptor biotechnology companyIndustryBiotechnologyTypePublic CompanyFounded2008Employees201-500CategoriesBiotechnologyB2BHealth CareMedicalPharmaceuticalManufacturingPharmaceuticalsMedicineChemical ProductsAcademic ResearchLaboratory ServicesSpecialtiesbiotechologypharmaceuticalimmunooncologyt-cellsinfectious diseaseoncologyimmtacsimmune systemhiringbiologicsautoimmunejobsscientistsregulatory affairsand cmcbiotechnologycancerinfectious diseasesautoimmune diseasest cell receptorimmunotherapyimmtaximmtacimmtavand immtaaiAbout the RoleThe Company is seeking a Vice President of Regulatory Affairs to lead a team in the development and execution of scientific and tactical regulatory strategies, submissions, approvals, and compliance throughout the drug development process. The successful candidate will be responsible for ensuring the team's consistent, efficient, and timely document development, as well as overseeing interactions with regulatory agencies. Key responsibilities include collaborating with global regulatory leads, aligning regulatory goals with business objectives, and providing strategic guidance on labeling, risk management, and post-marketing requirements. The role demands a proven track record in all stages of drug development, experience in scientific regulatory strategy, and a strong background in managing regulatory submissions globally. Candidates for the Vice President of Regulatory Affairs position at the company should have 15-20+ years' of experience in regulatory affairs within a biopharmaceutical organization, with a focus on biologics drug development. The ideal candidate will have a background in oncology, anti-infectives, or autoimmune disease, and must have led the preparation, submission, and approval of at least one NME. A strong educational background in a scientific discipline is required, with an advanced degree being desirable. The role also requires excellent communication skills, the ability to influence and gain credibility with stakeholders, and a proven track record of success in regulatory affairs. The candidate should be adept at managing a team, be flexible, and comfortable with ambiguity in a fast-paced, innovative environment.Hiring Manager TitleSenior Vice President of Regulatory SciencesTravel PercentLess than 10%FunctionsMedical Care/Hospital Administration