Regulatory Affairs Intern

Intern

1. 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.
2. Conduct research on regulatory requirements and guidelines applicable to generic pharmaceuticals in various markets.
3. Support the maintenance of regulatory files and databases, ensuring accuracy and completeness of documentation.
4. Collaborate with cross-functional teams, including Quality Assurance, R&D, and Manufacturing, to gather necessary information for regulatory submissions.
5. Assist in the review of labeling and promotional materials to ensure compliance with regulatory standards.
6. Participate in regulatory intelligence activities, including monitoring regulatory updates and communicating relevant information to internal stakeholders.
7. Provide administrative support as needed, including organizing meetings, preparing meeting agendas, and documenting meeting minutes.
8. Any other related duties as assigned by Project Leader

Master In Pharmacy

• Currently enrolled in a Bachelor's or Master's degree program in Pharmacy, Regulatory Affairs, Life Sciences, or a related field.
• Strong attention to detail and organizational skills.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Prior experience or coursework in regulatory affairs or the pharmaceutical industry is preferred.