Cadence VP Regulatory/Compliance
Cadence is a mission-driven retail pharma start-up leading an effort to move birth control pills to over-the-counter (OTC) status. The Cadence products are two FDA approved Rx oral contraceptives containing ethinyl estradiol, progestins and placebo reminder pills in tablet form and dispensed in blister packs. The mission of the company is to enable easy and affordable access to oral contraceptives nationwide and eventually internationally. Learn more at www.liberatethepill.com
The scope of responsibilities for this role is broad, commensurate with a start-up venture funded by impact investment. The regulatory lead may begin as a contract position either part-time or full-time, and evolve into a FT employee position on-site at our Oakland, CA office. This position requires a strong background in both regulatory affairs and quality assurance for both clinical development and CMC functions. Candidates should have the ability to lead a team (comprised of internal and external members) to develop regulatory strategy and execution. Candidates must be based in the SF Bay Area, and can work remotely up to 50% time.
- Develop and implement US regulatory strategy for Cadence OTC switch products, including clinical and CMC regulatory affairs.
- Serve as the primary interface for FDA.
- Lead the preparation of submissions, which may include INDs, Meeting Requests, Briefing Documents, and NDA supplements, and NDAs.
- Liaise with external regulatory operations group for management of eCTD submissions
- Oversee quality assurance functions.
- Lead the Cadence team in preparation and execution of FDA meetings and other regulatory agency meetings, as required.
- Represent Regulatory Affairs on cross-functional teams. Communicates, influences and negotiates effectively with cross-functional teams as regulatory representative.
- Interface with international affiliates on regional regulatory strategy and implementation plans.
- Maintain knowledge of regulatory environment, regulations and guidance.
- Participate in Corporate Development efforts, as needed, including facilitating regulatory and quality due diligence.
Qualifications - Skills/Knowledge Required:
- Degree in scientific discipline and RA certification.
- Clinical and CMC Pharmaceutical RA expertise required with RX to OTC experience desirable.
- A minimum of 10 years pharmaceutical industry with a minimum of 7 years in regulatory affairs. Global experience desirable.
- Thorough knowledge of drug IND, NDA and OTC switch processes.
- Demonstrated experience in preparing and managing INDs and NDAs submissions.
- Knowledge of FDA regulatory guidance as they relate to the overall regulatory strategy.
- Team-oriented, i.e. comfortable with collaborating as a cross-functional team and making decisions as a team.
- Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing activities simultaneously.
- Must be able to innovate, analyze and solve problems with minimal supervision.
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