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


COMPANY
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. 

LOCATION
Cambridge, MA

DESCRIPTION
• 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

REQUIREMENTS
• 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).