Remote- Senior Manager, Regulatory Affairs CMC (Vaccine)

A pharmaceutical manufacturing company is looking to bring on an additional Senior Manager, Regulatory Affairs CMC to the team. This position will report to the Associate Director of Regulatory Affairs CMC and will collaborate closely with the Regulatory Affairs CMC team, to help implement and coordinate regulatory activities with a primary focus on analytical methods/control strategy to support development of vaccines.

• Role: Senior Manager, Regulatory Affairs CMC
• Contract Length: 12+months
• Location: Remote
• Start Date: March 2023

Requirements

• Bachelor's degree preferably in a scientific field. An advanced degree is desirable.
• At least 8 years' experience in the biotechnology industry
• 5+ years preparing analytical sections of regulatory dossiers (IND, BLA, MAA).
• Background in vaccine development with knowledge of the vaccine development process is highly desirable.
• Expert knowledge of analytical methods for characterization, release, and stability testing of biologics is a must (vaccines preferred).
• Knowledge and experience with current GMPs and regulatory expectations for investigational and commercial products.
• CTD format experience
• Ability to work independently and within a group setting and to interact effectively with different functional department

Responsibilities

• Manage key regulatory CMC activities, including planning, writing, and reviewing of analytical sections/documents necessary to support regulatory submissions, including INDs, IMPDs, CTAs, BLAs, MAAs, and their supplements/variations, meeting requests, briefing packages, and responses to queries from regulatory agencies.
• Manage CMC regulatory submission strategies pertaining to Analytical submissions for US and International markets.
• Act as regulatory CMC analytical representative on project teams to ensure that development activities support and comply with the relevant regulatory requirements.
• 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.
• Provide regulatory guidance on development and maintenance of analytical control strategy.
• Provide strategic input on test method development, validation, verification, and transfer to ensure compliance with regulatory standards.
• Maintain up-to-date working knowledge on relevant regulatory regulations, guidance, and the current regulatory environment.
• Establish regulatory CMC processes and procedures and provide training to other departments
  

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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