17 days ago
In partnership with the Vice President of CMC Affairs, the Director CMC Regulatory Affairs acts as a regulatory lead for large molecules CMC programs by providing regulatory strategy and support to development teams.
Principle Responsibilities and Duties:
- Develop and execute CMC regulatory strategies for large molecule products in early-, late-development and commercialized products.
- Represents CMC Regulatory Affairs at project team meetings and coordinates workflow between departments
- Interfaces with external regulatory groups, such as contract manufacturers and development partners
- Coordinates, writes, compiles, document packages for regulatory submissions per regulations/guidelines and company SOPs to support regulatory applications including investigational and marketing applications (IND, CTA, BLA, MAA), etc.
- Maintains CMC Regulatory document control system.
- Acquires and maintains current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline areas relevant to assigned projects.
- Contributing to interactions with regulatory authorities as needed.
- Participates in department initiatives to improve standards and systems internally and maintain relationships with other departments including consultants and vendors.
Education, Experience and Background:
- BS/MS or PhD a in life sciences field
- Experience in Antibody Drug Conjugates
- Experience with large molecules “Monoclonal Antibody highly preferred”
- Writing experience “module 3” is a plus
- Chinese language proficiency preferred
- Ability to manage multiple and varied tasks in a fast-moving environment, with excellent project management skills.
- Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from a variety of multifaceted research activities, demanding regulatory requirements, and working collaboratively with pharmaceutical partners are required.
- Must be highly collaborative, with strong communication skills
What’s in it for you?
- Competitive Base/ Bonus/ Equity Package
- 401k with 7% employer matching
- Comprehensive Insurance plan
- Joining a $13 Billion worth company that never had layoffs and is planning for a 200% growth in 2022