Salary: $195,000-$220,000
Company Summary: A cutting-edge Biotech Oncology company located in the Bay Area is starting to grow its regulatory team by adding a Director with experience in Biotech and Investigational New Drug & Clinical Trial Application filings. The role will report directly to the CMO and play a pivotal role in crafting a regulatory team. Do you want to be a critical piece in regulatory for an incredible team with a track record of success in growing beast Biotechs in the Bay Area? Reach out!
Key Responsibilities:
- Build out a regulatory team to support the company pipeline
- Collaborate with leadership and CMO to guide drug development and strategy
- Manage preparation and submission of INDs, CTAs, and other applications to regulatory agencies.
- Supervise regulatory activities and ensure proper organization and submission
- Serve as primary point of contact for regulatory agencies
- Conduct meetings and planning to ensure quality of regulatory submissions and activities
- Represent Regulatory affairs and provide insight and guidance for leadership regarding regulatory issues and topics
Key Qualifications:
- 8 to 10 years of Regulatory Affairs experience in Biotechnology/Pharmaceuticals
- Extensive knowledge of all phases of drug development
- Ability to grow a regulatory team
- Strong leadership, communication, and interpersonal skills
- Strong IND and CTA experience
If you are interested in making an impact as a Director/Senior Director of Regulatory Affairs, don't wait to connect!
