Regulatory Affairs Intern

Intern

• Assist in the preparation and submission of regulatory documents to health authorities for product registrations, including ANDAs /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

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.