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)