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:
Strategy
vaccine

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

Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.