The Everest Group

*A division of The Everest Search Group, Inc., Los
  Angeles, CA
*The Everest Search Group Inc., Lake Tahoe, NV

Ranked Top 200 of America's Best Executive Search Firms in 2017 by Forbes

Senior Manager Global Regulatory Affairs Labeling

Our client is a multi-billion dollar biopharmaceutical company focused on innovative medicines for the treatment of cancer with over a dozen drug candidates in the pipeline. 

Cambridge, MA

• Supervise team of labeling professionals responsible for preparing high quality labeling submissions; including NDAs, amendments and supplements; in accordance with FDA guidelines.
• Insure assigned product labeling is accurate, up-to-date and in compliance with regulatory requirements by following established labeling content preparation and review procedures
• Participate in the preparation of the labeling submission documents and provide critical review of these documents prior to submission to the FDA.
• Assure that the team’s work is appropriately prioritized to achieve established business objectives. Evaluate labeling issues and provide accurate and timely recommendations and alternatives, as needed. 
• Position will interact with FDA; therefore, candidate must have a firm command of labeling regulations and guidances. 
• This position will continue to be a “hands on” position in regards to daily work but will also be expected to act on behalf of the Group Leader when assigned to do so.
• Coach, mentor and provide guidance to assigned team members. Develop new labeling employees into fully contributing labeling team members

• Bachelor’s degree preferably in regulatory affairs or scientific  
• Minimum of 5 years pharmaceutical labeling experience within the branded pharmaceutical industry
• Demonstrated competence in leading teams to successful outcomes and previous supervisory experience.
• Good communication skills and ability to work well with business partners as well as with RA team members.
• Knowledge of patent/exclusivity carve-outs, negotiations with the FDA and/or promotional materials desired.
• Proficient with electronic labeling filing and SPL (Structured Product Labeling); Proficient computer literacy (Microsoft Office, Excel, PowerPoint, Adobe PDF).