Senior Manager Regulatory Affairs Specialist

2 weeks ago

Plainsboro Center, New Jersey, United States Sun Pharmaceutical Industries, Inc. Full time
Join Our Team as a Senior Manager, Regulatory Affairs

At Sun Pharmaceutical Industries, Inc., we are committed to making good health accessible and affordable to local communities and society at large. We are seeking a highly skilled and experienced Senior Manager, Regulatory Affairs to join our team.

About the Role

The Senior Manager, Regulatory Affairs will be responsible for handling publishing and coordinating tasks for Global RA submission activities. This includes supporting the Global RA submission process and infrastructure, as well as collaborating with Strategists, Publishers, and various stakeholders on submission strategies.

Key Responsibilities
  • Support the Global RA submission process and infrastructure
  • Collaborate with Strategists, Publishers, and various stakeholders on submission strategies
  • Track and schedule submission activity (i.e. status, audit trails) and provide reports to upper management
  • Validate and QC of incoming and outgoing regulatory data/documents
  • Archival of other necessary submissions and/or documents
  • Review and QC final published submission documents before submitting to Health Authority (QC with respect to publishing aspects of the eCTD requirement)
  • Review and track the archiving of global eCTDs, paper submissions, and Health Authority correspondences using Regulatory Affairs systems/tool
  • Support, maintain, and update authoring templates
  • Assist functional areas with document-level requirements and best practice techniques for compliant authoring
  • Participate in infrastructural activities (i.e. support implementation of new tool/systems required by department and/or maintenance activities and enhancements)
  • Track, generate, and present Monthly snapshots and/or yearly metrics as applicable
  • Support in maintenance and update Health Authority Commitment tracker including post-approval commitment for the programs assigned to SPARC GRA/GRO and notify to the involved stakeholders
Requirements
  • Associate or Bachelor's Degree required
  • 3-5 years' experience in publishing and related tools/eCTD requirements
  • Effective timeline management and communications relative to submission components
  • Flexible with strong spoken and written communications skills and able to navigate and work in a diverse cross-cultural/cross-functional environment
What We Offer

At Sun Pharmaceutical Industries, Inc., we offer a comprehensive benefits package, including medical, dental, vision benefits, health savings account (HSA), flexible spending account (FSA), prescription drug coverage, telehealth and behavior health services, income protection – short-term and long-term disability benefits, retirement benefits – 401(k) company match on day one (100% vesting immediately), group life insurance, wellness programs, and corporate discounts on personal services.

We are an equal opportunity employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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