Director – Global Regulatory Affairs, CMC ** Fully Remote ** IND/CTA/NDA/BLA/MAAs ** Growing Biotech, Collaborative Culture, Good Pipeline!

Reference: 240313A

Expiry Date: 30-04-2024

Categories Biotech, Clinical Research, Manufacturing / Production, R & D, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Suffolk County
United States
Remote Working

Benefits:

  • Child Care
  • Dental
  • Flexible Hours
  • Medical
  • Life Insurance
  • Sick Days
  • Vacation
  • Vision Insurance

Apply for position

Job Description

Director – Global Regulatory Affairs, CMC  ** Fully Remote ** IND/CTA/NDA/BLA/MAAs ** Growing Biotech, Collaborative Culture, Good Pipeline!

Location: Fully Remote, with the Global HQ in Greater Boston.

We are looking for a collaborative Regulatory Affairs CMC professional with 10+ years of experience, who has led / co-led  US and EU projects with a track record of successful regulatory submissions and approvals including INDs/IMPDs/NDAs/BLAs/MAAs who can also develop and implement CMC regulatory strategies.

Responsibilities

  • Develop and create CMC regulatory strategies for multiple clinical development projects from early to late-stage clinical development.
  • Coordinate all aspects of the preparation, review and submission of regulatory documents.
  • Represent Regulatory Affairs, CMC as a member of cross functional project teams and provide guidance relating to changing global regulatory requirements.
  • Serve as the Company’s Regulatory Affairs Lead in interactions with global health authorities including the FDA, EMA, with respect to clinical submission documents.
  • Provide leadership and direction in the development of regulatory documents including INDs, CTAs, NDAs, BLA’s and MAAs.
  • Make submissions to global regulatory authorities, as required, and maintain an ongoing interactive relationship regarding these submissions.
  • Coordinate and maintain reporting schedules for regulatory applications.
  • Create and maintain Regulatory Strategic Development plans and provide strategic input in global product development planning.
  • Identify and communicate to executive management information about potential regulatory issues; propose risk evaluations and mitigation strategies.

This position will suit you if you like a collaborative environment, where regulatory has a strong voice, but there is also a clear and established pathway upwards, from Director to Snr Director and ED. The role is varied and has a bit of everything. It's both strategic and hands-on with leadership for both early and late-stage development indications with the opportunity to operate as the CMC  GRL for NDA/BLA/MAAs.

Our client is a growing BioPharma focused on Rare Diseases with a varied portfolio of exciting indications for both Biologicals and Small molecules. They have a strong and impressive leadership team, who have all been successful in launching indications, who are nimble, flexible and listen to their development teams…..you will find Regulatory has a big voice here! There is less bureaucracy and red tape and more collaboration and innovation. This is a people-led, not process-driven environment, which means more open dialogue and open debate where decisions can be made more quickly.  

On offer is a strong package, including a competitive East Coast basic salary, high bonus and good LTI scheme.

If you are interested in applying or discussing the role in more detail, please call me, Theo Moore on 587.216.9302 or email me your CV via Theo@AdvTalent.Com