Manager, Regulatory Affairs (CMC)

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Job Description

The Manager, Regulatory Affairs – CMC leads all CMC regulatory activities for ANDAs, supplements, and amendments. This role involves authoring and reviewing submissions, assessing change controls, coordinating cross-functional teams, interacting with regulatory agencies, and guiding the regulatory affairs team. The position ensures high-quality, compliant submissions that support the company’s product portfolio.

• Leading preparation and review of CMC sections for ANDAs, supplements, and amendments
• Reviewing technical data and providing regulatory/scientific assessments
• Evaluating change controls, deviations, and post-approval changes
• Coordinating with Quality, Manufacturing, Analytical Development, and R&D teams
• Monitoring regulatory guidelines and agency expectations
• Developing SOPs and best practices for submissions and change control
• Participating in audits and training activities
• Ensuring timely responses to regulatory agency queries
• Determining reporting categories for CMC changes
• Preparing and submitting post-approval documents (Annual Reports, CBE-0, CBE-30, PAS)
• Managing amendments, notifications, and lifecycle submissions
• Supporting site transfers, process and specification changes, validations, equipment and packaging updates
• Maintaining regulatory records, databases, version control, and document archiving
• Promoting continuous improvement, compliance, and knowledge sharing

Qualification and Experience

Qualification & Experience:

• Master’s degree in pharmacy, chemistry, pharmaceutical sciences, or related field; advanced degree preferred
• 4-6 years of experience in regulatory affairs focusing on CMC for ANDAs, supplements, and amendments in the
  pharmaceutical industry
• Proven experience in authoring, reviewing, and managing CMC sections for regulator submissions
  Strong knowledge of FDA and global regulatory requirements for generics, supplements, and post-approval changes.
• Demonstrated team leadership skills, including mentoring, coaching, and managing regulatory affairs
  professionals.
• Excellent cross-functional collaboration, analytical, and problem-solving skills.
• Strong written and verbal communication skills for drafting regulatory documents and interacting with agencies.
• Ability to manage multiple projects, prioritize tasks, and meet deadlines in a fast-paced environment.

Competencies