Regulatory Affairs Consultant
My client is a growing biotech company which develops cellular therapies for use in the treatment of patients with severe diseases and conditions. With two marketed products and two late-stage programs, they are looking to bring on a Regulatory Affairs Consultant to lead regulatory strategies and execution for an upcoming BLA.
Main Responsibilities:
- Provide regulatory expertise for new strategic areas and technologies as required for new product development
- Ensure program development complies with regulatory requirements appropriate for each stage of development in both US and globally, and lead interactions with regulatory agencies in the US and globally
- Ensure submissions are done on time, complete and accurate in accordance with regulations and corporate goals
- Act as the regulatory lead to ensure that activities are conducted in compliance with relevant laws, regulations, and guidance including with manufacturing, research, clinical, and quality assurance
Knowledge and Skills:
- Bachelor’s degree required. Master’s degree in life sciences or regulatory affairs a plus
- 10+ years of experience in regulatory affairs in pharmaceutical or biotech environment
- Strong knowledge of US and EU drug and biologic regulations, experience with rest-of-world drug and biologic regulations a plus
- Experience with fast track submissions and breakthrough therapy designations a plus
- Experience with IND and BLA submissions in eCTD format
- Strong leadership, interpersonal skills and the ability to work in a project team environment as well as with Senior Management
Number of hours worked per week: Minimum of 24+ hours a week with the ability to work more
Length of Assignment: 6 months with the ability to extend to 1 year
Position Location: Cambridge, MA