Director Regulatory Affairs CMC

Location: Redwood City, CA

Type: Full Time Permanent

Salary: Excellent salary, bonus and accompanying benefits package 

Exciting opportunity to join an exciting therapeutics company that is look to take patient treatment within Oncology to the next level with 2 upcoming BLAs in 2021. This vacancy provides the ability to grow and build out the Regulatory Affairs CMC function whilst assisting in the advancement of clinical products!

The Director of Regulatory Affairs CMC will be responsible in providing and developing strategic direction within Module 3 with the intention of successful registration. This person will provide leadership and a sense of urgency to cross-functional teams, as well as communicating with FDA and other regulatory agencies to formulate proper Regulatory strategy. This role is an individual contributor role that will require CMC writing and strategy, however there is the ability to eventually grow out the function and build a team with strong pipeline advancement!

RESPONSIBILITIES:

• Provide regulatory CMC leadership for all drug development projects to health authorities for regulatory submissions
• Serve as liaison between FDA and company for all CMC discussion/negotiations
• Define and develop CMC regulatory strategies
• Coordinating all CMC documentations submitted to FDA in support of INDs, BLAs, MAAs, DMFs, CTAs, amendment and annual updates
• Work in tandem with cross functional colleagues and be able to report accurately to exectuve stakeholders

EDUCATION/EXPERIENCE:

• MS required (PhD, MD, PharmD, or MS preferred) with proper experience.
• 8-10 years of regulatory affairs experience within Drug Development
• Prior experience preparing CMC regulatory documents including new INDs/CTAs/BLAS/MAA
• perience with manufacturing, process development, quality control, or quality assurance
• Prior experience and success with filing with FDA and Global Health authoriries

SKILLS:

• Well-rounded knowledge of FDA regulations and EU requirements
• Demonstration of strategic planning, meeting objectives, technical and resource issue resolution
• CMC specific regulatory knowledge and an understanding of manufacturing, process development, quality control, or quality assurance related to biologics, small molecules, biosimilars, and/or combination products

I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Bobby DeMarco at (646)-349-4344 or at b.demarco@hamlynwilliams.com