Director, Global Regulatory Affairs CMC | Exciting Pipeline, Top Pharma Industry Leader | Boston Area

Cornerstone Search Group
December 7, 2021
Greater Boston Area, United States of America
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Director, Global Regulatory Affairs CMC | Exciting Pipeline, Top Pharma Industry Leader | Boston Area


Our Client, a highly attractive global Pharma company has an exciting opportunity for a Director of Global Regulatory Affairs CMC to support small molecules or biologics (or both) in early and later stages of development and/or commercial products across multiple therapeutic areas.

This is a highly visible and impactful leadership role where you will manage staff, provide strategic regulatory leadership/guidance, and oversee the development and execution of regulatory CMC development and registration strategies for a diverse portfolio of products.

LOCATION: Boston, MA area | Relocation Assistance provided


  • High-Visibility & Ability to Impact: You will play a key leadership role in providing strategic regulatory CMC guidance for developing registration strategies for assigned products
  • Manage/Lead a Team: Lead team members that establish CMC content requirements for regulatory submissions
  • Enjoy the Best of Both Worlds: Enjoy the minimal layers of management, fast pace, and swift decision making of a biotech culture with collegial & collaborative atmosphere, while also enjoying the financial stability and the financial strength of an established global pharma (i.e. more financial and human capital resources, more assets, tremendous growth, etc.)
  • Cutting-Edge Therapeutics: You will be working with innovative and promising new treatments
  • Strong Collaborations / Financial Strength/ R&D Spend: Join a global industry leader with a track record of establishing multiple collaborations with top academic research centers, and with other innovative biotech companies too in a highly competitive marketplace.  This Company has strong revenues, profits, cash & market cap that invests heavily in its annual R&D.
  • Very Competitive Compensation/Benefits: This Company offers a very competitive compensation package and an extensive benefits package (strong LTI, 401k company contributions, employee stock purchase plan & much more).
  • Hybrid Working Model: Enjoy a hybrid working arrangement with a couple days on site


  • BS/BA degree (advanced degree preferred).
  • 9+ years of pharma/biotech industry Regulatory CMC experience, with global experience strongly preferred.
  • Experience liaising with Regulatory Agencies having served as lead in Agency Interactions and product development meetings.
  • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
  • Experience providing strategic regulatory guidance to drug development, registration, and post-market support teams. Ability to provide regulatory advice to make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
  • Experience with managing a team and/or direct/indirect reports.
  • Demonstrated leadership, flexibility, problem-solving ability, and strong communication skills.
  • Willingness to travel to various meetings.

CONFIDENTIALITY: All communications are treated as highly confidential information.


Viola Serrano | Senior Director, Executive Search


P: 973-656-0220 x734



Pharma/Biotech Executive Search Specialists | Forbes “Top 250 Search Firm” for 2018 & 2017

PO Box 5657 | Parsippany, New Jersey 07054 USA

Keywords: regulatory affairs, RA, CMC, pharmaceutical, biotech, development, cGMP, APIs, small molecules, biologics, recombinants, global, regulatory filings, submissions, FDA, IND, NDA, EMA, ICH, WHO, world regulatory agency, strategy, CMC product lead, leadership, leader, director, associate director

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