Job Listing: Mgr. of Drug Regulatory Affairs Labeling

Our client, one of the worlds largest and fastest growing pharmaceutical companies in the world, is looking for a Manager, Regulatory Affairs Labeling to join their team.

On a DAILY BASIS, the Manager of Drug Regulatory Affairs Labeling will be responsible for the following:

- Chair Product Label Review Team (PLRT) meetings for assigned marketed product with minimal assistance from Associate Director, including timely availability of preparatory documentation, identification of issues for discussion, comparison with Company Core Data Sheet, preparation of meeting minutes and follow-up of action items to complete resolution.
- Serve as back-up to Associate Director as needed, in bringing PLRT proposals to Product Labeling Committee (PLC) for discussion, review, and approval as required.
- Provide functional support to Associate Director (and serve as back-up) for discussions involving the Annual Labeling Review, Company Core Data Sheet Updates, and other ad hoc labeling issues as they occur for assigned marketed products.
- Review compliance of product labeling with the Company Core Data Sheet with the understanding of local health authority's regulations and guidelines; communicate potential deviations to the BPI Office prior to submission to FDA.
- Interact with business partners as appropriate to ensure consistency and compliance of product labeling and proactive communication of potential deviations, e.g., Corporate Design Office, BPI Office.
- Serve as regulatory representative across products for implementation of revised labeling in production (e.g. PCD process, RSPPs).
- Provide substantial support for preparing and maintaining official BIPI labeling files (hard copy and electronic). Review and analyze labeling files for historical information; prepare and review labeling section of NDA Annual Reports. Write reports for legal inquiries related to product labeling revisions.
- Coordinate preparation of regulatory labeling submissions initiated by the DRA Product Labeling Group with contributing functions in other departments.
- Review for completeness, consistency and accuracy of proposed changes and supportive documentation, making recommendations or suggestions back to the PLRTs or DRA Product Managers as appropriate; back-up to Associate Director as regulatory sign-off authority.
- Act as liaison with FDA as appropriate to achieve timely labeling reviews/approvals. Assist product manager in the DRA Product Groups with development of labeling for late stage NCEs/NBEs.
- Demonstrate proficient and current labeling knowledge. Invest substantial time to improve competency level in understanding and interpreting evolving regulations and guidances.
- Review regulatory developments with DRA Product Labeling Group and keep our company abreast of changes in the US regulatory environment impacting product labeling.
- Assist with training of DRA staff and other functions re: labeling processes as appropriate. Maintain excellent knowledge of applicable corporate/company SOPs, guidelines, and working instructions related to product labeling.

TO BE QUALIFIED for the Manager, Regulatory Affairs Labeling, individuals MUST have the following requirements:

- Minimum B.S./B.A. degree with 5-8 years pharmaceutical experience in DRA or scientific discipline, with 2 years labeling experience.
- Experience drafting and reviewing product labeling and compiling supportive documentation, and demonstrated competence in marketed product labeling maintenance.
- Capable of reviewing regulatory implications of non-clinical and clinical data to evaluate the regulatory implications for product labeling with substantial support and supervision.
- Basic knowledge of US regulatory labeling requirements.
- Detail-oriented, well organized and good planning skills.
- Excellent proofreading/editing skills are required
- Excellent communication (verbal, writing, and presentation) skills necessary for interacting with regulatory project managers and multi-functional labeling review teams.


All qualified individuals should contact Crysta Lemon at 203-317-2522 or via e-mail at clemon@aerotek.com.

Required Skills for Mgr. of Drug Regulatory Affairs Labeling Job:

About Aerotek Scientific:

Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.