Leadership Opportunity | Director, Global Regulatory Affairs CMC | Innovative Therapies, Global Biopharma | Boston Area

Cornerstone Search Group
Published
November 8, 2021
Location
Greater Boston Area, United States of America
Category
Job Code
vsNH3088csg
Contact Email
vserrano@cornerstonesg.com

Description

Leadership Opportunity | Director of Global Regulatory Affairs CMC | Innovative Therapies, Global Biopharma | Boston Area

SUMMARY:

Due to continuous growth and expansion, our Client, a highly attractive global biopharma has multiple openings for Directors of Global Regulatory Affairs CMC to support small molecules, biologics, and recombinants in early and later stages of development as well as commercial products across multiple therapeutic areas. These are highly visible & impactful leadership opportunities 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.

As GRA Director, you will manage regulatory submissions for assigned compounds in several phases of clinical development, global marketing applications, and post-approval life cycle activities, participate in global teams that require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations to ensure CMC compliance, evaluate new business development opportunities and/or represent GRA CMC on due diligence teams, and you will represent GRA CMC in Health Authority meetings.

LOCATION: Boston, MA area | Relocation Assistance

ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:

  • High-Visibility & Ability to Impact: You will play a key 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 biopharma (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 scenario with a couple days on site

QUALIFICATIONS/REQUIREMENTS:

  • BS/BA degree (advanced degree preferred).
  • 9+ years of pharma/biotech industry Regulatory CMC experience including experience as an RA CMC product lead, 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.

CONTACT:

Viola Serrano | Senior Director, Executive Search

E: vserrano@cornerstonesg.com

P: 973-656-0220 x734

LinkedIn: linkedin.com/in/violaserrano

CORNERSTONE SEARCH GROUP

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

PO Box 5657 | Parsippany, New Jersey 07054 USA

www.cornerstonesg.com

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

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