Vice President Regulatory Affairs
My client is driven to improve the lives of those affected by cancer and other serious illness. They currently have development programs in clinical trials, solid strategic pharma partnerships, and substantial long term financing. They are looking for a Vice President of Regulatory Affairs to develop and execute global regulatory strategies and lead agency interactions. In this role you will oversee all aspects of regulatory affairs, working closely with a CRO. This is a growing science-driven company with an open, collaborative culture and an advancing pipeline. The sky is the limit here when it comes to defining one’s career path.
Responsibilities:
- Establish and build the company’s regulatory function to support drug development and approval
- Lead, create, and drive global regulatory strategies for the company’s clinical and pre-clinical portfolio
- Lead and manage interactions with FDA and other health authorities
- Ensure effective input into the design, implementation and data analysis for clinical studies required for regulatory approvals
- Oversee and manage the preparation, submission, and maintenance of INDs, CTAs, NDAs, and other regulatory applications
- Author, review and critique documents that will be included in regulatory applications and interactions
- Provide clinical and non-clinical regulatory support to enable decision-making and regulatory approvals
- Inform leadership team of regulatory status of products and significant regulatory issues
- Keep peers and executive team apprised of changes to the regulatory landscape affecting existing and future products
- Provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning
Knowledge and Skills:
- BA/BS degree in a scientific disciple required. A doctoral degree (PhD, MD or equivalent) is strongly preferred
- Minimum of 12-15+ years of drug development experience (10+ years of Regulatory leadership experience) obtained in the biopharmaceutical industry with excellent knowledge of all aspects of the drug development process
- Must have regulatory experience in support of oncology and/or immunology programs
- Previous experience leading a regulatory function
- Must have led an NDA, BLA, or MAA in the past
- Demonstrated capacity for understanding how to take appropriate regulatory risk to drive projects to success
- Experience working in small and large organizations is preferred
- Experience working with corporate partners is preferred