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 Regulatory Affairs Immuno Oncology


We have been asked to find an innovative Senior Manager Global Regulatory Immuno-Oncology to be based in MA.

About the Company
Our client is an innovative leader in the biopharmaceutical industry with more than 30,000 employees globally, more than $20 Billion in revenue, and a diversified product portfolio focusing on a variety of therapeutic areas including Neurology, Immunology, and Oncology.

Some of the responsibilities include:

• Assist in preparation of global regulatory strategies
• Manage the submission and approval of applications for clinical trials (WW) and marketing applications, full submissions and variations in 3 ICH regions
• Represent GRA in Global Project Teams
• Lead GRA sub-team
• Manage the regulatory submission process through to approval including management and coordination of the preparation of all regulatory documentation
• Manage of the regulatory agency interactions, document preparation, co-ordination rehearsals and minutes (may be under supervision of a TA Head or delegate)
• Prepare regulatory strategies for projects (may be under supervision)
• Review of protocols, reports and all types of regulatory documentation (quality, safety, efficacy, and labeling) including CTAs
• Lead submission and approval of IND applications for clinical trials, original marketing applications (NDAs / BLAs, and post-approval applications (NDA / BLA Supplements)

Compensation
• Base $100,000 - $140,000+
• Bonus
• Long-term bonus
• Relocation
• Benefits







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