Senior Manager, Regulatory Affairs CMC (Remote)
Gaithersburg, MD US
Senior Manager, Regulatory Affairs CMC
Responsibilities include but are not limited to:
- Coordinate CMC Regulatory submissions, including CTAs/INDs, CMAs/BLAs and post-approval variations/supplements, Agency meeting requests, briefing packages, and responses to Agency comments and commitments.
- Communicate and coordinate with relevant functional groups and project team members to identify and ensure the preparation of required CMC documentation needed for regulatory submissions.
- Liaise with in-country regulatory leads for global submissions.
- Manage and track completion of source documents and eCTD sections.
- Maintain tracking tools for CMC regulatory information, including submission content plans.
- Liaise with the Regulatory Operations team on submission planning.
- 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.
- Maintain up-to-date working knowledge on relevant regulations, guidance, and the current regulatory environment.
- Bachelor's degree preferably in a scientific field. An advanced degree is desirable.
- A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC.
- Background in vaccine development with knowledge of the vaccine development process highly desirable.
- Knowledge and experience with preparation of global regulatory submissions (IND, CTA, BLA, or MAA).
- Knowledge and experience with current Good Manufacturing Practices (cGMPs) and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
- Experience with CTD format and content.
- Ability to work independently and within a group setting and to interact effectively with different functional departments.
- Experience with regulatory submissions to Health Canada, Australia, and New Zealand a plus.
- Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems.
- Detail-oriented with a focus on quality and compliance
- Strong project management skills, with the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
- Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook) and familiarity with electronic document management systems (EDMS) including Veeva Vault RIM.