Regulatory Intern

Sanofi Aventis Singapore Pte. Ltd; Singapore; On-site; SGD 15,000 - 18,000; Full time

Job summary

Sanofi Aventis Singapore Pte. Ltd in Singapore seeks a Regulatory Intern to assist the Regulatory Manager with worldwide pharmaceutical regulation filings and compliance at the site.

The role focuses on maintaining regulatory files, accurate documentation, and supporting inspections and audits. The intern will help monitor regulatory data for trends, assist with GMP certificates and site master file revisions, and support SOP revisions in line with global processes.

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.
• 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.

Skills

Regulatory documentation

Data entry

Regulatory filings

Compliance awareness

Tools

Regulatory databases

Documentation management

Job description

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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