Meet is currently partnered with a cutting-edge biotech who are focused on developing therapies in Regenerative Medicine. My client is searching for an Executive Director/Vice President, Regulatory Affairs to lead their team!
- Lead and manage the regulatory affairs team, providing strategic direction and guidance.
- Develop and implement regulatory strategies for product development and approval in collaboration with cross-functional teams.
- Interface with regulatory agencies to ensure clear and effective communication on regulatory submissions and approvals.
- Collaborate with internal teams to prepare, review, and submit regulatory documents, including INDs, BLAs, and other submissions.
- Minimum of 10 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
- Therapeutic area background in regenerative medicine, stem cell therapy, gene therapy, etc.
- Proven track record of successful interactions with regulatory agencies and obtaining regulatory approvals.
- Experience in managing regulatory affairs teams and excellent communication skills.