Senior Director, Regulatory Affairs
Company: Adamas Pharmaceuticals
Posted on: June 12, 2021
The Senior 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
- 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
- Subject matter expert in Regulatory Affairs in the
pharmaceutical industry; an effective collaborator with
- 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
- Fit with Adamas culture and values.
Keywords: Adamas Pharmaceuticals, San Francisco , Senior Director, Regulatory Affairs, Other , Emeryville, California
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