Regulatory Affairs Intern
DIFGEN PHARMACEUTICALS PRIVATE LIMITED
Date: 2 weeks ago
City: Hyderabad, Telangana
Contract type: Full time
- 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
- 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.
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