Remote: Associate Director Regulatory Affairs
Company: Shepherd Regulatory Search
Location: Saint Louis
Posted on: June 24, 2022
Organization: My client is a clinical-stage pharmaceutical company
striving to transform patient lives by developing innovative and
differentiated therapeutics to treat autoimmune, inflammatory, and
other debilitating diseases.
Role: Reporting to the Vice President of Regulatory Affairs, the
Associate Director Regulatory Affairs will assist with and manage
regulatory submissions and lead the development of strategies in
accordance with therapeutic area direction.
- Participate in cross-functional project teams to deliver
successful submissions/filings and outcomes with Health Authorities
(HA) for therapeutic programs
- Serve as a regulatory contact for designated trials: assist
with developing timelines, preparing and maintaining clinical trial
applications, track status of submissions, and Health Authority
commitments. Coordinate with CROs or vendors on clinical trial
activities in support of regulatory goals
- Collaborate with team members to draft responses to health
- Ensure consistency, completeness, accuracy, and adherence to
regulations and applicable guidelines for all regulatory
- Contribute to the regulatory strategy, including identifying
and communicating potential risks and mitigation plans associated
with regulatory strategies
- Contribute to interactions with Health Authorities, including
assisting in developing briefing packages and prep meetings
- Prepare regulatory operations Standard Operating Procedures
(SOPs); provide regulatory review of SOPs from other departments as
- This position is eligible to work from home, with occasional
travel to the office required, work from the office, or a
combination of working from home and the office.
- BA/BS degree, preferably in the life sciences, Advanced Degree
- Minimum 8 years of Regulatory Affairs experience is
- Direct experience in preparing registration (IND, NDA, CTA,
and/or NDS) submissions required.
- Track record of leading regulatory activities for development
- Strong knowledge of FDA guidelines for the development of small
molecule products is preferred.
- Experience working with Health Canada and filing CTA and NDS
submissions is preferred.
- Strong project management and organizational skills with
emphasis on attention to detail.
- 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.
- Experience working with CROs on regulatory submissions in
support of clinical trials.
- Proficient at using MS Office products.
- Experience with cloud-based document management programs and/or
document management systems and co-authoring tools is
- Ability to travel domestically and internationally as
Keywords: Shepherd Regulatory Search, St. Louis , Remote: Associate Director Regulatory Affairs, Executive , Saint Louis, Missouri
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