Associate Director Regulatory Affairs CMC
We are in search of an Associate Director of Regulatory CMC to be an essential part of my client’s organization. This company is a clinical stage biotech company that develops innovative protein therapies to treat various forms of cancer. They are rated as one of the top biotech companies in their space, with the largest library of proteins of any other company. This is an exceptional opportunity where you will be establishing their CMC function and instilling new methods related to CMC sections. In addition, you will have a seat at the table to institute best practices for manufacturing and development strategies. This position gives you an opportunity to become a senior member within a rapidly growing organization!
Responsibilities:
- Direct and implement CMC regulatory affairs strategies to support development programs
- Lead CMC sections for global biologic applications
- Serve as regulatory representative for select product development programs, including regulatory liaison with business partner(s), the FDA and other regulatory agencies
- Manage relationships with business stakeholders with responsibilities in process development, analytical development and quality to provide CMC support
- Plan regulatory milestones over the product lifecycle in coordination with cross-functional interdependencies
- Conduct regulatory risk assessments including risk mitigation
- Review technical reports and summary documents (CMC) for adherence to regulatory guidelines, strategies, and commitments
- Recommend regulatory policies to assure adherence to FDA requirements. Contribute to the modification, development and implementation of company practices and policies for Regulatory Affairs
- Provide regulatory expertise and policy support; educate others on regulatory policy and environment and impact to internal organization
Knowledge and Skills:
- BA/BS degree in Biology or Biochemistry; advanced degree desirable.
- 10 years of experience working in a regulated environment
- Regulatory CMC experience in managing major regulatory filing(s) such as IND or BLA
- Direct Regulatory CMC experience in biologics
- Strong strategic regulatory expertise across phases of drug development
- Experience leading, developing and implementing complex CMC regulatory strategy
- Extensive knowledge of FDA regulations, practices and ICH guidances
- Strong knowledge of global health authority regulations and practices
- Experience with nonclinical/clinical and/or companion diagnostics a plus
- Excellent verbal, written, negotiation, influence and interpersonal communication skills
- Previous experience in leading cross-functional teams