Regulatory Affairs Intern

DIFGEN PHARMACEUTICALS PRIVATE LIMITED


Date: 8 hours 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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