Regulatory Affairs Specialist

20 hours ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000

Job Description

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We are seeking a skilled Regulatory Affairs professional to join our team. As a key member of our regulatory team, you will be responsible for the preparation and submission of registration dossiers, renewal applications, and variation applications for ANDA/ROW submissions.

Key Responsibilities:

  • Preparation and submission of registration dossier, renewal application, and variation application for ANDA/ROW submission
  • Preparation of respective CTD sections and submission of final query response to agency
  • Preparation and submission of documents for national phase to respective European regulatory agency to receive national approval
  • Uploading documents in national portal for respective European regulatory agency
  • Co-ordination with different departments for getting required data for compilation of registration dossier, renewal application, and variation
  • Review of mockups for all regulatory submissions and commercial supplies
  • Maintenance of internal database
  • Co-ordination with consultant for national submissions, product information translation, readability testing, etc.
  • Review and approval of change control and deviations
  • Coordination with customer and consultant in order to timely submissions of new applications, query responses, variations, and renewals
  • Review of variation packages

Required Skills and Qualifications:

The ideal candidate will possess excellent communication and organisational skills, as well as the ability to work effectively in a team environment. Additionally, they should have experience with regulatory affairs, pharmaceutical industry knowledge, and proficiency in Microsoft Office.

Benefits:

Our company offers a competitive salary, comprehensive benefits package, and opportunities for career growth and development.

Others:

This is an exciting opportunity to join a dynamic team and contribute to the success of our organisation. If you are a motivated and results-driven individual who is passionate about regulatory affairs, we encourage you to apply for this role.

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