Senior Associate CMC Regulatory Affairs

Role & Responsibilities

• Prepare and submit new product registrations and post-approval variations

• Author and review CMC Modules 2 and 3 (eCTD format)

• Handle EU & CIS regulatory filings and agency queries

• Manage product lifecycle management (PLCM) activities

• Support new product launches, extensions, and tenders

• Ensure compliance with global regulatory guidelines

• Maintain regulatory tracking tools and documentation

• Coordinate with internal teams and health authorities

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• Qualification

  • Bachelor’s degree in Pharmacy, Chemistry, or related discipline

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  Experience

  • 2+ years of experience in CMC Regulatory Affairs

  • Hands-on experience with EU regulatory submissions

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  • Skills

    • CMC Module 2 & 3 authoring

    • eCTD documentation

    • EU pharmaceutical regulations knowledge

    • Strong documentation and regulatory writing skills

    • Excellent communication and coordination skills

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    • About the Company

      • ClinChoice is a global clinical research and regulatory solutions organization

      • Provides end-to-end regulatory, compliance, and clinical support to pharmaceutical and biotech companies

      • Known for international regulatory submissions across EU and CIS regions