RA CMC Director for Cell and Gene (REMOTE) *** Work on development & commercial stage Cell and Gene therapy products!

Reference: ODT513O

Expiry Date: 24-01-2023

Categories Biotech, Regulatory Affairs

Salary: On Application

Job Type: Full Time

Fulton County
United States
Remote Working

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Job Description

Location: US East Coast / Fully Remote

Our client is a successful global Biotechnology company dedicated to bringing transformative Cell and Gene therapies to patients with serious and life-threatening orphan diseases. They have a strong and established leadership team and a highly experienced regulatory team that have already been successful in registering a Cell and Gene product, so the DNA of success already runs through the organisation.

Their late-stage pipeline is very exciting, and my client has a good amount of indications ready to start the registration process, with 3 major BLA/MAA’s planned in the next 18 months, and more indications steadily coming through the pipeline.

My client is now looking for a Regulatory Affairs CMC Associate Director or Director to join their dedicated Global Regulatory Affairs CMC team. The focus here is on collaboration and sharing the workload, and its important that you have the ability to prioritize workloads/responsibilities and respond effectively to program changes. Strong interpersonal skills including verbal and written communication are essential in this dynamic and collaborative working environment.

This will be varied role, where you will be leading and/or supporting all the different aspects needed around a successful BLA/MAA, both strategic and hands-on, as you plan, author, review and submit high quality CMC modules of marketing authorization filings.

Suitable candidates will enjoy jumping in as and when needed, working closely as a team, handling multiple tasks in parallel and have prior Cell and Gene experience in either early stage development (P1/P2) OR late stage development (P3) and have BLA experience gained on other Biologics. This is a role where you will need to enjoy the lead up to a registration.

Responsibilities may include:

  • Developing strategies and partnering with key stakeholders to execute on the strategies in alignment with business priorities
  • Providing Regulatory CMC leadership to Technical Operations and CMC teams in line with US, European, ICH, and other applicable regulatory requirements
  • Planning, authoring, reviewing and submitting high quality CMC modules of investigational and marketing authorization filings
  • Participating in the definition and implementation of (CMC regulatory strategy for assigned program(s)
  • Regularly assessing information (CMC) gaps and communicating regulatory risks and related mitigation measures associated with assigned program(s) to senior management and program team(s)
  • Regularly reviewing and providing regulatory assessment of change controls
  • Utilizing electronic systems such as Veeva for dossier creation and tracking for CMC sections of regulatory filings


To Apply!

Please contact me, Theo Moore on 908.348.6714 or send your CV to CV@AdvTalent.com and I will immediately reply with details on how I will progress your application.

LinkedIn: https://www.linkedin.com/in/theo-moore-b33696a/