Regulatory Affairs Director
Company: Dennis Partners
Location: San Francisco
Posted on: January 15, 2021
Regulatory Affairs Director or Associate Director Posted on:
October 1, 2020 This small but growing Bay Area pharmaceutical
company has one approved product and a very strong pipeline of
novel therapeutics for the treatment of rare diseases. They are
seeking a Regulatory Affairs Director or Associate Director that
can contribute to and execute on regulatory strategies for multiple
programs in development. This individual will be responsible for
the preparation and submission of global applications while also
interacting with regulatory authorities. Now is an exciting time to
join this innovative organization and improve the lives of patients
around the world!Responsibilities:
- Develop and implement global regulatory strategies for multiple
programs in development including rare disease indications.
- Prepare, coordinate, and manage various regulatory submissions
including INDs, CTAs, orphan drug applications, NDAs, and routine
- Lead cross functional project teams while providing regulatory
expertise, project management oversight, direction, planning, and
- Prepare for and participate in interactions with FDA and global
- Identify, drive, track and deliver on key
- Serve as primary liaison with outside contractors to obtain and
complete regulatory documents/data.
- Provide regulatory expertise and policy support for good
pharmaceutical development practices (GCPs, GMPs and GLPs)
- Prepare regulatory operations Standard Operating Procedures
(SOPs); provide regulatory review of SOPs from other departments as
- Act as key liaison for ordering publications, guidelines, FOI
requests, etc. for the department.
- Participate in regulatory intelligence activities; review draft
regulatory guidelines and monitor trends.Knowledge and Skills:
- BS. in a scientific discipline; advanced degree (MS, PhD, Pharm
- 8+ years of experience in Global Regulatory Affairs for
pharmaceutical drugs and/or biologics.
- Direct experience in preparing regulatory submissions (INDs,
CTAs) required. Experience with Marketing Applications (NDA, BLA,
and/or MAA) a plus.
- Strong knowledge of FDA/ICH and foreign regulations and
guidelines for the development of small molecule drug
- Experience with rare disease indications a plus.
- Strong project management and organizational skills with
emphasis on attention to detail
- Regulatory Affairs Professional Society or similar certificate
- Excellent interpersonal and verbal/written communication skills
with the ability to build relationships at all levels of the
- Ability to work independently on multiple projects with tight
timelines and minimal supervision.
- Able to handle multiple projects and exercise good judgment in
- Must be a team player who is comfortable wearing many hats in a
small biotech environment.Apply for this Position Your Name*
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Keywords: Dennis Partners, San Francisco , Regulatory Affairs Director, Executive , San Francisco, California
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