Associate Director, Regulatory Affairs CMC (Remote)
Gaithersburg, MD US
We are seeking a highly motivated and experienced individual for an Associate Director position in Regulatory Affairs CMC. This position will report to the Senior Director, Regulatory Affairs CMC Drug Product Team. The position will work in close collaboration with the Regulatory Affairs CMC DP Team to implement and coordinate all aspects of regulatory activities as needed to support the global development of investigational vaccines through licensure and beyond.
Responsibilities include but are not limited to:
- Lead key regulatory CMC activities including planning, writing, and reviewing documents necessary to support PFS regulatory submissions, including supplements/variations, meeting requests, briefing packages, and responses to queries from regulatory agencies.
- Assist with CMC regulatory submission strategies pertaining to the Drug Product and combination (device/medicinal) products for US and international markets.
- Act as regulatory CMC DP/PFS representative on project teams to ensure that development activities support and comply with the relevant regulatory requirements.
- Provide Regulatory CMC support for introduction of new PFS facilities into our regulatory applications
- Maintain up-to-date working knowledge on relevant combination product regulatory regulations, guidance, and the current regulatory environment.
- Manage and track completion of source documents and eCTD sections
- Facilitate communication and coordination with Global Project Management for key CMC Regulatory deliverables
- Ensure that overall regulatory 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 CMC documentation and data needed for regulatory submissions.
- Establish regulatory CMC processes and procedures and provide training to other departments.
- MS or Ph.D. In a biological science or related discipline.
- A minimum of 10 years in the biotechnology industry with at least 8 years in regulatory affairs, including experience with pre-filled syringe regulatory submissions.
- Background in vaccine development with knowledge of the vaccine development process is highly desirable.
- Experience with post-approval changes (variations and supplements)
- Good understanding and experience with current GMPs and regulatory expectations for investigational and commercial products.
- Experience with CTD format and content.
- Ability to work independently and within a group setting and to interact effectively with different functional departments.
- Ability to work in a fast-paced and dynamic environment with changing priorities.
- Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.