Associate Director, Regulatory Affairs - CMC

Job Description

The Associate Director, Regulatory Affairs – CMC will lead global regulatory CMC strategy for product development and registration, and prepare CMC dossiers for small molecule regulatory submissions.

Qualifications

• Bachelor’s degree in scientific discipline with 7-8 years Regulatory Affairs experience and/or CMC technical writing experience.
• Advanced degree preferred, particularly in scientific disciplines relevant to the field.
• Technical knowledge in small molecules, experience translating to regulatory documents.
• Experience in pharmaceutical development, registration, and post-approval life cycle management in a global environment.
• Prior experience in GMP environments and understanding of industry regulations and best practices.
• Knowledge of global regulatory guidance and ICH region regulations for small molecule drugs.
• Experience in preparing regulatory submissions, including IND/CTA, NDA/MAA, NDS, briefing documents, and response to agency queries.
• Excellent collaboration, communication, problem-solving, and organizational skills.
• Ability to work independently and collaboratively in a fast-paced, matrixed team environment.
• Proficiency with Microsoft Office.

Benefits

Base salary range: $169,100 – $212,800. Additional benefits include medical, dental, vision, retirement savings plans, and short- and long-term incentives.