The Regulatory Intern is responsible to assist the Regulatory Manager for ensuring compliance with relevant worldwide Pharmaceutical Regulation & API regulatory filing (e.g. CEP,CMC, Drug Master File (DMF), New Drug Application (NDA), JNDA, NDS & Marketing Authorisation Application (MAA) of the site.
Main Responsibilities
- Support to maintain and update regulatory files and databases
- Ensuring accurate and timely documentation of regulatory activities
- Participating in regulatory inspections and audits, providing regulatory support and documentation
- Providing the regulatory support during site inspections
- Support to monitor data for the regulatory performance to identify trends and issues and to implement action plan
- Support on the Manufacturing licence, GMP certificates and revision of the site master file
- Support to revise SOPs and any other document relevant to Regulatory Affairs.
Additional Responsibilities
- Support Change Control process for the site. Follow up on change plans/actions to ensure compliance to change control process
- Support continuous improvement initiatives on site, in line with global processes and practices
- Other responsibilities that are not included in the above but are related to quality assignments.
