Associate Director, CMC Regulatory
Vanda Pharmaceuticals
Full-time
Remote friendly (Washington, DC)
United States
Corporate Functions
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Role Summary
Associate Director, CMC Regulatory. Responsible for reviewing and preparing CMC sections, ensuring regulatory compliance, and developing regulatory strategies for submissions and post-approval variations.
Responsibilities
- Review drug substance and drug product information for completeness and up to current regulatory standards
- Prepare CMC sections for drug substance and drug product information/data
- Review relevant FDA/EMA/ICH guidelines to ensure completeness
- Prepare responses to FDA/EMA questions
- Develop regulatory strategy for original submission and post approval variations
- Perform regulatory assessment on CMC change controls
- Participate in drug substance and drug product development activities to ensure appropriate data for INDs/NDAs/IMPDs/MAAs are generated
- Work with contract manufacturing companies to address any gaps in information/data
- Collaborate with drug substance, drug product and analytical chemistry subject matter experts to prepare CMC sections
Qualifications
- MS or PhD degree in pharmaceutical sciences or medicinal chemistry
- ~8 to 10 years pharmaceutical R&D experience with at least 3 to 5 years of regulatory CMC experience
- Thorough knowledge and understanding of biologics and sterile products
- Good writing skills