Senior Manager, Regulatory Affairs CMC (Remote)

Gaithersburg, MD

Posted: 07/12/2023 Industry: Scientific Job Number: 23-00305

Job Description

Senior Manager, RA CMC
Preferred qualifications:

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.

Minimum Requirements:
  • 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.

Meet Your Recruiter

Mark Bookbinder

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