Vice President Regulatory Affairs (Full-Time Contract)
My client is a growing biotech company with a wide array of treatments for cell therapy. They are perceived in the marketplace as a leader in developing cellular therapies for treatment of patients with severe diseases and conditions. With two marketed products, they are looking to bring a Vice President of Regulatory Affairs to lead the company’s global regulatory strategy and execution from new product conception to post marketing.
Main Responsibilities:
- Manage agency interactions related to both IND and BLA developments
- Be the point of contact for the existing BLA under review with the FDA
- Work with the consultants in CMC, Quality, and Operations related to agency meetings and regulatory affairs related projects
- Oversee and manage all pre-clinical regulatory functions supporting the company’s clinical and manufacturing programs
- Provide regulatory support of commercialized products
- Participate in the development of corporate strategy and policies
Knowledge and Skills:
- Minimum BS required, MD/PhD or PharmD highly preferred
- Minimum 10 years of senior regulatory experience
- Must have knowledge of FDA regulations and good cross functional practices (GXP)
- Must have successful experience with regulatory submission and approval
- Strong interpersonal skills and management experience
- Experience with biologics required
- Must have experience with BLAs and/or NDAs
Number of hours worked per week: 30-40 hours
Length of Assignment: 4 months (Contract has potential to be renewed after this point up to 6 months)
Position Location: Boston, MA Area