The Director, Regulatory Affairs will play a key role in setting regulatory strategy for developmental and commercial Adamas assets, including all advertising and promotional activities. The incumbent will be responsible for generation of necessary documentation and interacting with regulatory agencies for successful regulatory submissions supporting the Company’s programs. Primary responsibilities include providing expertise in translating regulatory requirements into practical, workable plans, preparation of critical submission documentation and communications with business partners and FDA for assigned projects. Responsibilities include participation in Adamas’ general regulatory affairs and regulatory compliance functions. This position may manage the activities of other regulatory affairs staff or contract regulatory support in the performance of the duties outlined below. This position based in Emeryville, CA and reports to the Vice President, Regulatory Affairs.
- Develops and implements commercial regulatory strategy by partnering with the commercial organization to understand the Company’s promotional objectives; applies the “consistent with labeling” guidance accurately; ensures relevant OPDP letters are understood and applied
- Develops and manages the systems, policies, and procedures that govern the Company’s commercial review committee; chairs this committee; drives efficient and timely “concept” review
- Manages assembling documentation for regulatory submissions to INDs, CTAs, NDAs, amendments, supplements, and annual reports that meet regulatory standards.
- Provides regulatory strategy for product development candidates and maintenance of approved products.
- Ensures a clear understanding of post-approval regulations and requirements
- Manages outside consultants.
- Provides regulatory oversight and guidance regarding strategy for regulatory projects that pertain to Adamas products.
- Provides oversight and guidance to the assembly of documentation for submission to regulatory authorities.
- Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.
- Bachelor’s degree in biology, chemistry, or health-related discipline (Master’s degree preferred).
- At least 10 years pharmaceutical industry experience in both large and small companies that have successfully launched products
- Subject matter expert in Regulatory Affairs in the pharmaceutical industry; an effective collaborator with cross-functional teams.
- Experience in pharmaceutical/life sciences industry.
- Experience writing and assembling the supporting documentation for INDs and other regulatory filings.
- Detail-oriented with the ability to detect and correct errors and/or inconsistencies in a variety of documents.
- Excellent interpersonal and follow-up skills.
- Ability to work successfully within a team/collaborative environment, with a high level of professionalism.
- Proficient with Microsoft Office applications, Word, Excel, Project and PowerPoint.
- Successful experience in fast-paced entrepreneurial environment.
- Fit with Adamas culture and values.