Global Regulatory Affairs (GRA) Labeling Associate

This Global Regulatory Affairs (GRA) Labeling Associate position will ensure active adherence to the local and global labeling processes using the appropriate tools and systems to ensure harmonization and compliance with company and GMP standards and specifications. This Global Regulatory Affairs Labeling Associate role will have the specific duty to fully lead and write a United States Package Insert (USPI) for a particular assigned product in preparation for a US BLA submission.

This position will contribute to the Quality Enhancement Plan (QEP) through continuous and vigilant evaluation of labelling compliance via the Labelling Change Control process and the end to end labeling process flow. The position will do this by strictly following both local and global procedures. The Global Regulatory Affairs Labeling Associate will participate in scientific, technical and operational exchanges with Clinical Development, Pharmacovigilance, Medical Affairs, Marketing, Industrial Operations, Legal, Regulatory Affairs Franchise and Global Labeling as necessary to ensure labeling documents and associated change requests are medically and scientifically accurate and that they comply with company standards, and meet company needs.

Key Accountability:
Enhance the scientific contribution of the GRA Labeling group and work in concentration with Clinical Development, Pharmacovigilance and Medical Affairs on-site and/or globally.
Represent GRA Labeling department on product and project teams by interfacing with other functions and leading particular projects and products through completion and/or licensure where appropriate.
Achieve consistency in labeling and Regulatory labeling process through regulatory standards, cross functional collaboration and interactions with health authorities where appropriate.
Contribute to the label control, format and design of packaging for leaflets, cartons and labels of specific products and coordinate implementation of labeling components in collaboration with Industrial Operations where appropriate.
Actively participate in regulatory aspects of internal project plans and ensure timelines are met and milestones are achieved.

Focus will be on the details of the scientific/medical documentation required to ensure accurate and complete label development, evaluations, reviews, and approvals. Need to contribute to productive yet challenging relationships with cross-functional areas to ensure integrity and quality of Regulatory output.

Skills:
4-8 years prior Regulatory Affairs or relevant industry experience.
Demonstrated experience with biopharmaceuticals and management capability
Business Certification and/or experience preferred.

Bachelor's degree in scientific field preferred.
Advanced degree preferred.

For more information, Please contact

Best Regards,
Akriti Gupta
(973) 967-3409
Morristown, NJ 07960