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Thursday, 24 April 2014

CMC Regulatory Affairs Team Manager

CMC Regulatory Affairs Team Manager, New Delhi
ExecuPharm, Inc - New Delhi, Delhi
A Leading Global Top 10 Pharmaceutical company based in New Delhi are looking for the best talent to join their expanding team. If you are an experienced Regulatory Consultant and you are looking for your next step in your career then this could be the role for you.

The Role and your Responsibilities

  • Execute maintenance of chemical and pharmaceutical manufacturing and control (CMC) documentation for worldwide registration.
  • Correspondence and interaction with scientists, functional areas and subsidiaries to support in-line product filings worldwide.
  • Maintain working knowledge of current governmental and worldwide requirements for post-approval changes
  • Ensure consistency in practices, champions best practices and promotes operational excellence
  • Understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders
  • Participate in initiatives to promote Operational Excellence
  • Support new and existing CMC systems
  • Identify and promotes best practices within CMC
  • Provide effective supervision (if applicable) by reviewing documents as necessary to ensure the quality, accuracy and timeliness

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