Regulatory Affairs Specialist
Newark Metro Area, NJ
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 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.
Achieve consistency in la
beling and Regulatory labeling process through regulatory standards and cross functional collaboration
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.
Prepares and maintains text documents of country-specific labelling for submission and approval by health authorities.
Prepares regulatory labelling submission dossiers. Prepares responses to questions pertaining to labelling from regulatory authorities and from functions affiliates and distributors.
Proofreads and approves text contents of country-specific mock-ups for regulatory submissions and EU, US and Standard Export artwork for production/printing.
Performs other regulatory labelling duties as required (e.g., coordinates Labelling Change Control workflow).
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.
4-8 years prior Regulatory Affairs, packaging coordination or relevant industry experience.
Demonstrated experience with biopharmaceuticals and management capability
Business Certification and/or experience preferred.
Bachelor s degree in scientific field preferred.