Regulatory Intern

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.

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