Associate Director/Director, Regulatory Affairs
Company: System One
Posted on: April 10, 2021
Associate Director/Director, Regulatory Affairs Job
Title:--Associate Director/Director, Regulatory Affairs
Address: 21 Firstfield Road Gaithersburg MD 20878 United States
Remote can be 100% remote but EAST COAST
Type: Direct Hire
Has this position been approved by finance?--Yes
Is credit approved by our Corp? Yes
How quickly do you need someone to fill this role (what is their
Are you currently considering internal candidates?--NO
Client's JD: We are seeking a highly motivated and experienced
individual for an Associate Director/Director position in
Regulatory Affairs (Nonclinical/Clinical). This position is located
at our Gaithersburg, MD facility and will report to the Senior
Director of Regulatory Affairs. The position will work in close
collaboration with the Regulatory Affairs and cross-functional
teams to develop, implement, and coordinate all aspects of
regulatory activities with a primary focus on nonclinical and
clinical regulatory strategy and execution to support the continued
development of Novavax's investigational vaccines through licensure
and beyond. This role will have primary responsibility for
regulatory development and strategy for our NanoFlu program.
Responsibilities include but are not limited to:
- Lead the development of regulatory strategies for
investigational and ultimately commercial vaccine products
throughout the product lifecycle with a primary focus on the
- Lead and execute key regulatory activities, including planning,
writing, and critical review of documents necessary to support
regulatory submissions, including INDs/CTAs, BLAs/MAAs, meeting
requests, briefing packages, responses to queries from regulatory
agencies, pediatric plans, etc.
- Review and quality control of nonclinical and clinical
documents for compliance with regulatory requirements.
- Support initiation and maintenance of global regulatory filings
for clinical trials in US, Europe, Latin America, Asia-Pacific, and
Africa, and serve as regulatory liaison with Clinical Research
- Ensure that project timelines are aligned cross-functionally
and support the coordination and preparation of timely regulatory
- Communicate and coordinate with relevant functional groups and
project team members to identify and ensure the preparation of
required documentation and data needed for regulatory
- Act as primary regulatory representative on internal project
teams and for other project development activities to ensure that
development activities support and comply with relevant regulatory
- Maintain up-to-date working knowledge on relevant regulatory
regulations, guidelines, and the current regulatory environment.
Provide updated information on regulatory issues to project teams
and other personnel.
- Establish regulatory processes and procedures and provide
training to other departments.
- Bachelor's degree preferably in a scientific field; advanced
- A minimum of 10 years in the biotechnology industry with at
least 8 years in Regulatory Affairs.
- Background in vaccine or biologics development; knowledge of
the vaccine development process is highly desirable.
- Solid understanding of the drug development process, including
experience with developing regulatory strategies for
investigational products leading to licensure; experience leading
at least 1 BLA or NDA is desired.
- Flexible, detail-oriented, and willing to work in a dynamic and
fast-paced environment while managing multiple priorities.
- Show strong initiative and drive; must be an organized
- Ability to work independently, within a group setting, and
interact effectively across cross-functional departments.
- Strong communication skills (oral, written, and interpersonal);
critical-thinking and ability to identify and recommend solutions
Keywords: System One, Washington DC , Associate Director/Director, Regulatory Affairs, Executive , Gaithersburg, DC
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