Executive Director, Regulatory Science
Orchard Therapeutics
Vice President, CMC Regulatory Affairs
Iovance Biotherapeutics, Inc.
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Leads the development and implementation of all CMC regulatory strategy to support global development programs and market applications for cell therapies
- Responsible for ensuring the appropriate execution of CMC regulatory strategy
- Provide strategic and operational leadership and ensure effectiveness of the CMC Regulatory Affairs team
- Lead preparation of CMC-related submission planning, risk assessments, and ensure high-quality, accurate submission documents completed within target timelines
- Build and manage relationships with internal and external stakeholders and work across functions
- Ensure CMC dossiers meet ICH format and local country requirements; stay current with regulatory requirements and initiate process improvements
- Analyze complex CMC issues, interpret and discuss data with cross-functional teams and health authorities
Requirements
- Experience in biologics drug development, market applications and commercial lifecycle
- Bachelor’s degree in life sciences required
- 20+ years of pharmaceutical / biopharmaceutical industry experience
- 15+ years of relevant biologics experience in Regulatory Affairs CMC
- Demonstrated track record of successful submissions to FDA and/or other health authorities, including EMA
- Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
- Extensive regulatory management experience and in developing innovative regulatory solutions
- Ability to motivate and lead others
- Excellent interpersonal, verbal and written communication skills and ability to effectively lead and influence others
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- Advanced degree preferred (PhD, MD, MD/PhD)
