Associate Director, CMC Regulatory
The Associate Director, CMC Regulatory Specialist will be responsible for preparing and reviewing CMC documentation for drug substance and drug product, ensuring compliance with FDA, EMA, and ICH guidelines, and supporting regulatory trategies for submissions and post-approval changes. The role also includes collaborating with internal and external experts, managing regulatory assessments, and addressing gaps in data from contract manufacturing organizations.
Job 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
Job Requirements
- 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
Must be able to perform the essential functions of the position, with or without reasonable accommodation; however, reasonable accommodations will be provided for qualified individuals with disabilities unless doing so would impose undue hardship.
The total compensation package for this position will also include incentive compensation and benefits such as health insurance, unlimited paid time off, parental leave, a 401k matching program, and other benefits to its employees.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, gender identity, sexual orientation, protected veteran status, or any other characteristic protected by law.
If you reside in a state or locality with enacted pay transparency laws, you are entitled to request and receive additional details regarding compensation and benefits. For assistance, please contact us at 202-524-8238 between 8:00 AM and 5:30 PM ET, Monday through Friday.