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Investigo Limited
,
Gloucester, Gloucestershire
Vice President Regulatory Affairs
Overview
We're looking for a candidate to fill this position in an exciting company. The VP of Regulatory Affairs will report directly to the CMO and be responsible for managing and leading the regulatory activities with the full development, operational responsibilities and the global strategy for the life-cycle of the drug, from inception to post marketing for all products in the pipeline. VP will continue to build out the regulatory team and expected to drive the strategic nature of the oncology development process. In addition to managing the group and outside units, the VP of Regulatory Affairs will ensure timeliness of deliverables; reviewing/approving regulatory documents; and work with staff in resolving regulatory issues and/or problems, while ensuring the company adheres to all applicable regulations. Direct experience leading a regulatory team for all pre-IND, IND, NDA and other regulatory reports and documents. Early and late stage drug development experience through post-marketing and commercial phase. Extensive Oncology experience and knowledge 10 years of direct management and leading experience Advanced degree (MD/PhD) in life sciences with 15 years of experience in a biotech/pharmaceutical setting within regulatory affairs