Senior Executive Manager 2 Role

6 days ago


Vadodara, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 14,95,000 - ₹ 24,90,000
Job Title: Senior Executive Manager 2 - Regulatory Affairs

In this role, you will be responsible for leading the submission process for new products and variations, responding to regulatory queries, and ensuring compliance with regulations. Your expertise in Regulatory Affairs will play a critical role in driving business success.

The ideal candidate will have strong leadership skills and be able to work effectively with cross-functional teams to achieve goals. You will also be responsible for reviewing documents such as development reports, scale-up reports, specifications, stability protocols, and artworks before initiation of exhibit batches for adequacy.

Key Responsibilities:
  1. New Submissions:
    • Review and prepare CMC dossiers for fresh submissions.
    • Review documents for adequacy before initiation of exhibit batches.
  2. Approval:
    • Review and prepare responses to deficiency enabling approval of products filed to regulatory agencies.
  3. Lifecycle Management for Drug Formulations:
    • Prepare and review variations as per country requirements to support approval of changes such as API vendor changes, changes in ROS test parameters, DF site changes, and harmonization of products.
    • Prepare and review PCH dossiers and submit them to regional offices and regulatory agencies.
  4. Regulatory Compliance:
    • Ensure comprehensive product information is repositioned into a central repository.
    • Review regulatory filing impact of variations and change controls.
Requirements:
  • Educational Qualification: M.Sc or M.Pharm
  • Experience: 2-8 years

This is an excellent opportunity to grow professionally and contribute to the success of our organization. If you are passionate about Regulatory Affairs and possess strong leadership skills, we encourage you to apply for this challenging role.



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