A
Regulatory Affairs Intern
Aveva Drug Delivery Systems
Hyderābād
Internship
0-3 Years experience
Description
- Assist in the preparation and submission of regulatory documents to health authorities for product registrations, including ANDA/MAA/ANDS/IND but not limited to these.
- Conduct research on regulatory requirements and guidelines applicable to generic pharmaceuticals in various markets.
- Support the maintenance of regulatory files and databases, 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
About Aveva Drug Delivery Systems
-