Director, CMC Regulatory Affairs

 

The Opportunity:

Our client is a top 10, multi-billion dollar, world-leading biopharmaceutical company with a presence in over 60 countries. They are investing heavily in their expanding large molecule business. They have an outstanding reputation in the industry and its collaborative culture makes it a great place to work.

The timing could not be better to explore this unique opportunity; joining them now will allow you to “make your mark” on the upcoming BLA of their flagship biologic product. Not only will this allow you to make a big impact on their business and for their patients, but it will also be a credential that will benefit you for the rest of your career. Opportunities like this, to do something truly special, are rare and may only come along once or twice in a career.

Key Responsibilities:

  • Lead a Regulatory Affairs CMC team through upcoming BLA submission
  • Develop global regulatory CMC strategies for biologics programs (and some small molecule)
  • Prepare and review regulatory documents and interact with FDA and other agencies
  • Direct activities through all phases of development
  • Network internally and build relationships with cross functional leaders
  • Develop, mentor, and manage direct report staff

Key Requirements:

  • Strong background in Regulatory CMC Biologics
  • Proven management experience
  • Working knowledge of electronic submissions requirements
  • Excellent communication, negotiation and influencing skills
  • Experience interacting with the FDA
  • Willing to learn and manage small molecule assets


Interested candidates may submit their resumes in strict confidence to:

Angel M. Luisser @  aluisser@marcusassoc.com

Marcus & Associates | Life Sciences & Healthcare

Executive Search, Interim Services, & Consulting

Cell: 330.749.1988 (Call or Text)