Regulatory Affairs Intern
Summary
Assist regulatory affairs team at a pharmaceutical company in preparing and submitting documents to health authorities (ANDAs, MAA, DCP), tracking global regulatory updates, maintaining documentation, and collaborating with QA, R&D, and Manufacturing teams on compliance matters.
- Assist in the preparation and submission of regulatory documents to health authorities for product registrations, including ANDAs/MAA/DCP/ANDS etc but not limited to these.
- Periodic tracking of evolving Global Regulatory updates and updating to team and implimentation of the new expectations of Global competent Regulatory Agencies and review of all relevant data inclusive of the Type II DMF/ASMF etc.
- Support the maintenance of regulatory files and databases, PLCM, ensuring accuracy and completeness of documentation.
- Collaborate with cross-functional teams, including Quality Assurance, R&D, and Manufacturing, to gather necessary information for regulatory submissions.
- Assist in the review of labeling and promotional materials to ensure compliance with regulatory standards.
- Participate in regulatory intelligence activities, including monitoring regulatory updates and communicating relevant information to internal stakeholders.
- Provide administrative support as needed, including organizing meetings, preparing meeting agendas, and documenting meeting minutes.
- Any other related duties as assigned by Project Leader