CMC Regulatory Affairs - Small Molecule

Job Title: CMC Regulatory Affairs Specialist/Manager – Small Molecules

Location: Remote
Experience: 10+ Years

Job Summary

We are seeking an experienced CMC Regulatory Affairs professional with expertise in small molecule drug development to support global regulatory submissions and lifecycle management activities. The candidate will be responsible for preparing, reviewing, and managing Chemistry, Manufacturing, and Controls (CMC) regulatory documentation for investigational and marketed products.

Key Responsibilities

• Prepare, review, and submit CMC sections for regulatory filings, including INDs, NDAs, ANDAs, MAAs, amendments, supplements, and annual reports.
• Develop and execute CMC regulatory strategies to support product development and commercialization.
• Author and review Module 2.3 and Module 3 CTD/eCTD documents.
• Collaborate with cross-functional teams, including Analytical Development, Formulation Development, Manufacturing, Quality Assurance, Quality Control, and Supply Chain.
• Assess regulatory impact of manufacturing changes, process improvements, and site transfers.
• Support regulatory responses to health authorities such as the FDA, EMA, MHRA, Health Canada, and other global agencies.
• Ensure compliance with ICH guidelines, GMP requirements, and applicable regulatory standards.
• Coordinate preparation of deficiency responses, information requests, and agency meeting packages.
• Support product lifecycle management activities, including variations, supplements, renewals, and post-approval changes.
• Maintain regulatory documentation and submission records in regulatory information management systems.

Required Qualifications

• Bachelor''''s or Master''''s degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or related discipline.
• 10+ years of experience in CMC Regulatory Affairs supporting small molecule pharmaceutical products.
• Strong knowledge of ICH guidelines, CTD/eCTD structure, and global regulatory requirements.
• Experience with IND, NDA, ANDA, MAA, and post-approval submissions.
• Understanding of pharmaceutical development, manufacturing processes, analytical methods, and stability programs.
• Experience interacting with global health authorities is preferred.
• Excellent written and verbal communication skills.

Preferred Skills

• Experience with regulatory publishing tools and document management systems.
• Knowledge of FDA, EMA, Health Canada, and international regulatory requirements.
• Strong project management and stakeholder management skills.
• Ability to work independently in a fast-paced environment.