Regulatory Affairs Sr Manager

Regulatory Affairs Sr Mgr Responsibilities

• Formulate and present CMC regulatory strategies aligned with corporate objectives across investigational and marketed products.
• Develop risk registers for major regulatory submissions, including mitigation proposals.
• Coordinate preparation of CMC components of regulatory submissions.
• Guide and contribute to CMC-related documents for regulatory submissions, Health Authority meeting requests, and briefing books to meet regulatory standards and be approvable on first review cycle.
• Develop strategies and prepare responses to CMC-related topics with health authorities.
• Review manufacturing/testing change controls and provide regulatory impact assessments.
• Represent and support CMC regulatory on multidisciplinary project teams; provide CMC regulatory guidance.
• Ensure compliance with Health Authority expectations and regulatory guidance.
• Maintain and communicate knowledge of current/emerging CMC regulatory environments, guidelines, and best practices.

• Master's degree (or foreign equivalent) in Regulatory Science, Environmental, Safety and Health management or related field + 6 years' experience in the job offered or in an Associate or regulatory-related occupation.
• 6 years' experience in:
  • Leading interactions with Regulatory Agencies (briefing documents, meeting logistics).
  • Organizing/preparing/reviewing CMC content for clinical trial or marketing applications.
  • Compiling CMC quality data using Veeva Vault.
  • Developing/ managing project timelines and deliverables.
  • Knowledge of international drug-development standards (GLP, GCP, GMP).
  • Knowledge of FDA organization, roles, and responsibilities for drug development.
  • Analyzing, summarizing, and interpreting scientific data considering limitations.

• Stock; retirement; medical, life and disability insurance; eligibility for annual bonus or other incentive compensation (per job posting).