CMC Regulatory Affairs Specialist


Remote, Remote



CMC Regulatory Affairs Specialist

We are seeking CMC Regulatory Affairs Specialist who can help us provide Regulatory CMC consultation and technical writing services to biotech, biosimilar, and combination therapy companies engaged in research, development, manufacturing, and clinical trials. Projects span a full range of product types, including biologics, vaccines, gene therapies, tissue and cell therapies, biosimilars, and combination drug-device products.

As a member of this team you will work collaboratively with other team members and with client companies to support the development of global CMC submission strategies and content plans for the lifecycle of products. Successful candidates must have at least 5 years of experience in the Regulatory CMC space and possess working knowledge of industry-standard biologics manufacturing and/or analytical techniques. The candidate must be comfortable distilling technical information from multiple sources into concise and well-crafted written deliverables that are aligned with our highest standards of quality and meet both client and health authority expectations. Crazy-good ninja-like attention to detail and communication skills are absolute musts.


Minimum of 5yrs Regulatory CMC and submission experience

Minimum of 5yrs biologics manufacturing or analytical experience (live virus or cell & gene therapy a plus)

Candidate will be needed to support a wide range of Regulatory CMC strategy and writing support services, such as the following:

  • Develop sound and defendable strategies and skillfully message those strategies to help clients navigate the complex Regulatory CMC landscape and achieve desired results.
  • Prepare Quality submission packages for products in all stages of development (IND/IMPD/CTA/DSUR; BLA/MAA/JNDA; PAS/CBE/AR/PACMP).
  • Author, advise, and review briefing books for agency meetings and responses to agency questions.
  • Advise technical teams on regulatory perspectives for product development topics and on work packages to ensure they satisfy agency expectations.
  • Liaise between Regulatory and Technical lines (including CMOs/CROs) to achieve client objectives.
  • Support pre-approval inspections through building of storyboards, assisting with mock inspections and risk assessments, coaching SMEs, scribing, and managing support team communications, document retrieval, and coordination.
  • Author and review technical documentation including protocols and reports (eg, technology transfers, comparability demonstrations, stability studies, and PPQ/CPV), as well as commercial control strategies, change controls, investigations, SOPs, policies, and job aids.
  • Support due diligence efforts and perform gap analyses.
  • Provide mentorship and help develop junior staff

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