Vice President, Regulatory Affairs About the Company Excelling biotechnology (BioTech) company
Industry
Biotechnology
Type
Privately Held
Founded
2017
Employees
201-500
Categories BiotechnologyB2BHealth CareMedicalTherapeuticsPharmaceuticalsMedicineManufacturingChemical Products Specialties cancerpharmaceutical researchfunctional genomicsdrug discoveryand synthetic lethality About the Role The Company is seeking a Vice President, Regulatory Affairs to join their dynamic team. The successful candidate will be a key leader in driving the development of innovative global regulatory strategies for the advancement of precision oncology therapies. This role requires a minimum of 15 years' of relevant biopharmaceutical industry experience, with at least 10 years' specifically in Regulatory Affairs, and a deep understanding of the regulatory landscape in the context of oncology, with a preference for precision medicine. The VP, Regulatory Affairs will be responsible for leading a high-performing regulatory team, providing global regulatory leadership, and partnering with cross-functional teams to advance molecules from early development through to registration.
Candidates for the VP, Regulatory Affairs position at the company should have a Bachelor's degree in a relevant field, with an advanced degree being desirable. The role demands a professional with a strong background in interacting with regulatory health authorities and a proven track record of successful submissions, particularly in the areas of CTA/IND and BLA/MAA filings related to oncology. The ideal candidate will have a solid working knowledge of the drug development process and regulatory requirements in major markets, and the ability to proactively identify and address regulatory issues. Strong leadership qualities, excellent communication skills, and the ability to work effectively in a collaborative, fast-paced, and science-driven environment are essential. The VP, Regulatory Affairs will also be expected to contribute to the due diligence process for collaborations, offering regulatory assessments and insights.
Hiring Manager Title
President, R&D
Travel Percent
Less than 10%
Functions Medical Care/Hospital Administration
