Executive Director, Global Regulatory Affairs | Lead RA Strategy & Report to CSO | Successful CDMO | Remote

Cornerstone Search Group
Published
July 19, 2021
Location
REMOTE | Northeast Area, United States of America
Category
Job Code
cmNH2816csg
Contact Email
cmiras@cornerstonesg.com

Description

Executive Director, Global Regulatory Affairs | Lead RA Strategy & Report to CSO | Very Successful CDMO | Remote/Home Based or HQ-Based      

SUMMARY:

This Executive Director of Global Regulatory Affairs role provides a highly visible opportunity where you will be able to make significant contributions to the Sr. Leadership discussions and decisions that will influence and impact the Global Regulatory Strategies decided upon for new and existing generic pharmaceutical products. You will report directly to the Chief Scientific Officer/CSO, and you will lead a team of ~9 Global Regulatory Affairs Team Members based in the US and EU.

This is a very attractive time to join this well-established and profitable Specialty CDMO that will be intelligently and aggressively leveraging its proprietary technologies to expand its product offerings and global footprint—they already have 40+ unique generic products approved and marketed in over 100 countries.

LOCATION: This Executive Director position can be remotely based (work from home), or it can be based at one of the Company’s Northeast or Midwest locations

ATTRACTIVE FEATURES INCLUDE (AMONG OTHERS):

  • Influence RA Strategy: you will have opportunity to provide significant input to RA product & filing strategies
  • Impact: your RA strategy contributions will impact the development and outcome of new product offerings
  • Seat at Sr. Leadership table: you will be part of the Sr. Leadership team that makes key RA decisions   
  • Manage & develop others: you will lead and mentor a team of RA professionals based in the US and ED
  • Great time to join: this is a great time to join a proven CDMO winner that is well-established and profitable, and that has unique proprietary technologies that it plans to leverage intelligently and aggressively to expand its product offerings and global footprint beyond its already 40+ approved products commercialize in 100+ countries
  • Compensation and benefits: receive a competitive compensation and benefits package that includes equity participation so that you will also participate in the upside and financial success of the Company

QUALIFICATIONS/REQUIREMENTS:

  • Education: BA/BS an Advanced degree is a plus, but not required
  • A proven track record of progression within Regulatory Affairs
  • Experience providing input and influencing Regulatory Affairs Strategies, especially in the areas of CMC strategy, and ANDA and 505(b)(2) filings strategies
  • Strong communication and presentation skills
  • Experience leading/managing other Regulatory Affairs Team Members

CONFIDENTIALITY: All communications are treated as highly confidential information.

CONTACT:

Cliff Miras | Managing Partner

E: cmiras@cornerstonesg.com

P: 973.656.0220 x755

LinkedIn: linkedin.com/in/cliffmiras

CORNERSTONE SEARCH GROUP

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

www.cornerstonesg.com

Keywords: Executive Director, Senior Director, Sr, Regulatory, Affairs, CDMO, Contract Development and Manufacturing Organization, Filings, Submissions, ANDA, 505(b)(2), CMC, Global, Strategy, Strategies, Branded, Generic, Label, Labeling, CMC, BA, BE, Bioavailability, Bioequivalence, Health Authorities, FDA, EMA, ICH, EU, regulations, guidelines, SOP, compliance, quality, manage, lead, direct, mentor, leadership

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