This is a Retained Search. Our client is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. They are seeking a Vice President, Head of Regulatory Affairs to oversee the global regulatory process for all development programs. In this newly created role, you will be responsible for architecting regulatory development strategy, advising on regulatory risk, and leading interactions with regulatory agencies on behalf of the company. With a unique scientific platform and a strong pipeline, now is an exciting time to join this growing organization and help to get innovative new medicines approved!
- Develop and execute on US and global regulatory strategies (clinical, non-clinical, CMC and commercial) for a portfolio of clinical-stage product candidates.
- Provide guidance, direction, and leadership on those strategies to the development team and senior management.
- Oversee regulatory filings (IND, BLA, etc.) including authorship of critical documents as needed.
- Make strategic contributions to clinical development plans.
- Prepare meeting requests and briefing documents. Coordinate and prepare teams for Health Authority meetings.
- Interface with regulatory authorities and serve as the primary liaison with regulatory authorities for day-to-day interactions.
- Maintain up-to-date working knowledge of US laws, regulations, and guidelines as well as familiarity with the global regulatory environment.
- Identify and collaborate with regulatory experts and consultants.
- Coordinate and prepare responses to requests for information from regulatory authorities
- Represent the regulatory function on cross-functional development team(s).
- Establish, update, and implement regulatory policies, standards, and procedures for the company.
- Ensure operations in are compliant with FDA, ICH, EMA, and industry standards.
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables.
- Hire, train and lead the regulatory affairs team to support the growing pipeline.
- Maintain team budget and resource planning.
- Bachelor’s degree in life sciences; advanced degree (PhD, MS, PharmD, MD) preferred.
- 15+ years’ biopharmaceutical experience, including at least 10+ years of direct experience in Regulatory Affairs.
- Regulatory affairs experience with innovative biologic programs (antibodies, proteins, cell therapy, gene therapy, etc) desired
- Track record of successful IND, CTA, NDA, and/or BLA submissions. Global filing experience highly desired.
- Experience with CMC Regulatory for biologic programs desired but not required.
- Proven ability to prepare for and lead meetings with the FDA and other health authorities.
- Extensive knowledge of clinical development, FDA regulations, and international global clinical trial regulations.
- Knowledge of GxP regulations and ICH and FDA guidelines.
- Regulatory Affairs Certification (RAC) or education in a regulatory field preferred.
- Ability to blend analytical and critical thinking skills to enable data-driven, strategically oriented review of regulatory documents.
Interpersonal, Leadership, and Soft Skills:
- Demonstrated communication, problem-solving, and negotiation/decision-making skills.
- Natural collaborator who enjoys working on a cross-functional team.
- Proven ability to hire, build, and lead a Regulatory team.
- Able to manage multiple projects, set priorities and meet deadlines.
- Must be comfortable being an individual contributor, a team player, and a team leader.
- Proven ability to lead cross functional teams, serving as a strategic and tactical bridge between multiple areas.
- Must be comfortable in a small company environment. Able to be flexible and comfortable with ambiguity.