Associate Director/Director, Regulatory Affairs

Company: System One
Location: Gaithersburg
Posted on: April 10, 2021

Job Description:

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 urgency)? ASAP--

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 NanoFlu program.
• 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 Organizations (CROs).
• Ensure that project timelines are aligned cross-functionally and support the coordination and preparation of timely regulatory submissions.
• 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 submissions.
• 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 requirements.
• 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 degree desirable.
• 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 self-starter.
• 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 to problems.

Keywords: System One, Washington DC , Associate Director/Director, Regulatory Affairs, Executive , Gaithersburg, DC