We are looking for Regulatory Affairs Specialist (CMC) to support Chemistry, Manufacturing & Controls (CMC) activities for our client in Indonesia. This role is responsible for preparing, reviewing, and managing CMC documentation to support product registrations, variations, renewals, and lifecycle management. The position works closely with Manufacturing, Quality, and Regulatory Affairs teams to ensure that all technical dossiers are accurate, complete, and compliant with local and international regulatory standards.
Key Responsibilities
- Prepare complete registration dossiers in collaboration with Manufacturing and Regulatory Affairs for new registrations and ongoing product lifecycle activities.
- Support CMC-related submissions, including variations, renewals, and responses to health authority queries.
- Propose practical technical solutions to address regulatory requirements or deficiency letters issued by health authorities.
- Review and evaluate technical documentation, identify gaps or non-conformities, and coordinate required updates such as stability studies, analytical method validation, or process validation.
- Verify that technical documents comply with applicable standards (e.g., ACTD, ICH) and ensure alignment with corporate or regional guidelines.
- Manage Change Control processes for CMC-related topics, including changes to API suppliers, manufacturing sites, or production processes.
- Maintain strong collaboration with cross-functional teams, including Product Development, Quality Assurance, Regulatory Affairs, and global partners.
- Provide timely dossier support for site projects and ensure all submissions meet regulatory timelines.
Qualifications
- Bachelor's degree in Pharmacy, Chemistry, or a related scientific discipline.
- Minimum of 3 years experience handling technical dossiers or regulatory documentation within the pharmaceutical industry.
- Strong understanding of quality control, manufacturing processes, product development, and fundamental regulatory requirements.
- Effective coordination skills when working with cross-functional teams (local and regional).
- Excellent English communication skills, both written and spoken.
- Highly detail-oriented, well-organized, and able to work independently.
- Willing to be based in South Cikarang.
