Senior Manager Regulatory Affairs

4 weeks ago

US Trenton NJ USA Sun Pharmaceutical Industries, Inc. Full time
Job Title: Senior Manager, Regulatory Affairs

Sun Pharmaceutical Industries, Inc. is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for handling publishing and coordinating tasks for Global RA submission activities.

Key Responsibilities:
  • Coordinate and manage various programs and projects for which SPARC GRA/GRO is responsible.
  • Stay up-to-date with current Global Regulatory filing requirements and eCTD structure.
  • Collaborate with Strategists, Publishers, and stakeholders on submission strategies.
  • Track and schedule submission activity, providing reports to upper management.
  • Validate and QC incoming and outgoing regulatory data/documents.
  • Archival of submissions and documents.
  • Review and QC final published submission documents before submitting to Health Authorities.
  • Track archiving of global eCTDs, paper submissions, and Health Authority correspondences using Regulatory Affairs systems.
  • Support and maintain authoring templates.
  • Assist functional areas with document-level requirements and best practice techniques for compliant authoring.
  • Participate in infrastructural activities, such as implementing new tools and systems required by the department.
  • Track, generate, and present monthly snapshots and yearly metrics as applicable.
  • Support maintenance and update of Health Authority Commitment trackers, including post-approval commitments for programs assigned to SPARC GRA/GRO.
Requirements:
  • Associate or Bachelor's Degree required.
  • 3-5 years' experience in publishing and related tools/eCTD requirements.
  • Effective timeline management and communication skills relative to submission components.
  • Flexible with strong spoken and written communication skills and ability to navigate diverse cross-cultural/cross-functional environments.
About Sun Pharmaceutical Industries, Inc.

Sun Pharma is a leading provider of valued medicines, trusted by healthcare professionals and patients, to over 100 countries across the globe. Our Global Code of Conduct governs every aspect of our operations, and we are committed to making good health accessible and affordable to local communities and society at large.

We offer a comprehensive benefits package, including hybrid work arrangements, medical, dental, and vision benefits, health savings accounts, flexible spending accounts, prescription drug coverage, telehealth and behavior health services, income protection, retirement benefits, group life insurance, wellness programs, and corporate discounts on personal services.

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