Regulatory Affairs Intern
Summary
Supports the regulatory affairs team by preparing submissions to health authorities for drug delivery product registrations, tracking global regulatory updates, and maintaining compliance documentation while collaborating with QA, R&D, and Manufacturing teams.
- 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