Sr. Manager/Manager of Global Regulatory Affairs CMC role | Innovative Pipeline, Global Biopharma | Boston Area

Cornerstone Search Group
Published
November 11, 2021
Location
Greater Boston Area, United States of America
Category
Job Code
vsNH3091csg
Contact Email
vserrano@cornerstonesg.com

Description

Sr. Manager/Manager of Global Regulatory Affairs CMC role | Innovative Pipeline, Global Biopharma | Boston Area

SUMMARY:

Our Client, a highly attractive global biopharma with a diverse pipeline of products has a number of very attractive openings for Senior Manager/Manager for 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 impactful regulatory positions where you will be empowered to develop and lead the execution of regulatory CMC investigational, registration, and post-approval strategies for assigned products.

As a Senior Manager/Manager working on the Global Regulatory Affairs CMC team, you will be the regulatory affairs CMC member on Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle. You will develop and apply a comprehensive understanding of global RA CMC regulations and guidelines to projects to enhance probability of regulatory success and regulatory compliance, and you will successfully communicate with international Health Authorities as necessary.

LOCATION: Boston, MA area | Relocation Assistance

ATTRACTIVE FEATURES ABOUT THIS COMPANY & OPPORTUNITY:

  • Ability to Impact: You will help develop and lead the execution of regulatory CMC strategies for assigned products
  • High-Visibility: As a GRA CMC product leader / team member, you will ensure and enhance regulatory compliance with respect to filing requirements to achieve global regulatory success
  • 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).
  • 6+ years of pharma/biotech Regulatory CMC experience, including experience as an RA CMC product lead, or equivalent industry experience. (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
  • Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
  • Ability to provide 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.
  • Demonstrates strong communication skills, emerging leadership, flexibility, problem-solving ability, attention to detail, and values collaboration and teamwork.
  • 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, GRA, CMC, drug substance, pharmaceutical, biotech, development, cGMP, APIs, small molecules, biologics, recombinants, global, regulatory filings, submissions, FDA, IND, NDA, BLA, world regulatory agency, strategy, CMC product lead, manufacturing, senior manager, manager, sr. manager, regulatory specialist, regulatory consultant

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