Regulatory Affairs Coordinator

hace 1 semana


Victoria de Durango, Durango, México Novartis Farmacéutica A tiempo completo

About the Role:

As a Regulatory Affairs Coordinator at Novartis Farmacéutica, you will play a critical role in ensuring the timely supply of products to the market while maintaining compliance with current regulatory obligations and requirements.

Key Responsibilities:

  • Regulatory Transmission: Serve as the single point of contact for worldwide regulatory intelligence information, maintaining partnerships with RA CMC members and management to stay up-to-date on new regulatory requirements, strategies, and knowledge of global product dossiers.
  • Change Control: Support the site in generating effective change control strategies from a Regulatory Affairs CMC perspective, verifying and monitoring regulatory relevant changes, and providing regulatory strategic guidance as a member of the local change control board.
  • Submission Support: Facilitate timely provision of good quality source documentation, co-authoring as applicable, and accurate comments from technical experts to RA CMC while ensuring regulatory compliance, quality oversight, and adherence to best practices.
  • Health Authority Responses: Provide guidance and support for the preparation of CMC responses to Health Authority questions, balancing internal and external customer focus while considering Novartis global interests.
  • Declarations: Maintain oversight and ensure consistency, contribute to the establishment of standards, align requirements with RA CMC and RA, and provide guidance on the implementation of requirements into declarations.

About Novartis Farmacéutica:

Novartis Farmacéutica is a leading pharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines to improve and extend people's lives.



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