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Regulatory Affairs Coordinator

hace 2 meses

Victoria de Durango, Durango, México Healthcare Businesswomen'S Association A tiempo completo
Job Summary

We are seeking a highly skilled Regulatory Affairs Coordinator to join our team at the Healthcare Businesswomen's Association. As a key member of our regulatory team, you will be responsible for ensuring 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 and strategies.
  • 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, involving 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 for site-specific products, balancing internal and external customer focus 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 to implementation of requirements into declarations.
  • Local Products: Maintain close contact with local RA to follow regional regulatory trends and requirements, cooperating to formulate the regulatory strategy based on information at the site.
Requirements
  • Degree in Science (e.g., Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) with 6+ years of experience in pharmaceutical manufacturing with a focus on QA or regulatory affairs.
  • Project management experience.
  • Fluent English (oral & written).
  • Proven excellence in successfully collaborating with interdisciplinary teams while simultaneously planning, coordinating, and leading activities on multiple projects.
  • Excellence in negotiation and communication skills as well as capability to influence others in a matrix organization.
  • Knowledge experience of local and global regulations, submissions, and approval processes for new registrations and product life cycle management.
  • Proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements.
  • Computer literacy in Microsoft Office applications, document management systems, databases, and ability to quickly learn new software, tracking tools, and associated processes.
  • Proactive and action-oriented attitude and proven success in driving projects.