What are the responsibilities and job description for the Senior Vice President Regulatory Affairs position at ERAPS - Executive Regulatory Affairs Professional Search?
VP / SVP of Global Regulatory Affairs
Company Overview
My client is a revolutionary biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using a unique approach that starts and ends with patients, they leverage the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer. This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.
Summary
Forget what you've heard about other clinical stage oncology companies! My client is setting the stage by hiring a team that respects regulatory's voice, vision and take charge abilities. Reporting to the President of R&D, you will lead all Regulatory aspects for the company and will drive the global development regulatory footprint for innovative global strategy utilizing precision medicine for a Crispr technology platform. You will be tasked in the preparation and submission of high‑quality sections of briefing documents, INDs, CTAs, and eventual original marketing applications (BLAs / MAAs), in close collaboration with Nonclinical, CMC, Quality, and Clinical teams, as well as external consultants and collaborators, as needed.
Your Vision
- You will provide global regulatory leadership to support development of multiple, innovative therapies for oncology
- Maintain, manage, and develop a high performing regulatory team
- You will partner with key team members to develop strategies to advance our molecules from IND through pivotal studies and registration, leveraging a deep understanding of the landscape of precision oncology
- Drive the planning and implementation of meetings with regulatory authorities and effectively represent Tango with regulatory interactions
- Understand and interpret complex scientific issues for assigned projects as they relate to regulatory requirements and strategy for assigned projects, and provide knowledge and expertise to guide the team in appropriate regulatory strategy
- Proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation
- Manage and implement planning, authoring, and submission of high-quality briefing documents and clinical trial applications in the US, EU, Japan, and ROW
- Direct point of contact with health authorities, lead and manage FDA / global health authority interactions / meetings for project responsibilities; prepare and submit responses to queries
- Drive adherence to global regulatory guidelines relevant for the development of oncology products; author, review, and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals
- Identify and implement processes, procedures, and systems appropriate for company size and stage
- Provide Regulatory assessment to due diligence teams in terms of risks, requirements, and opportunities associated with collaborations
- Bachelor’s degree in life sciences, biochemistry, chemistry, biology or related pharmaceutical fields including biochemical engineering; advanced degree is desirable
- Minimum 15 years of relevant biopharmaceutical industry experience, with at least 10 years' experience in Regulatory Affairs and deep experience in oncology products
- Experience leading regulatory health authorities and experience with submitting CTA / IND and BLA / MAA filings, ideally in an area related to oncology
- Excellent written and verbal communication skills, strong technical knowledge, including regulatory writing (there is a Regulatory Writer on your team)
My client possesses a "hire no jerk policy" and possess a healthy culture based on humility.