Executive Director – Global Regulatory Affairs Head | (Remote Based): RETAINED SEARCH

Cornerstone Search Group
April 14, 2021
REMOTE, Greater Boston Area, United States of America
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Executive Director – Global Regulatory Affairs Head | (Remote Based): RETAINED SEARCH


You will be the Top Global Regulatory Affairs (GRA) professional with this well-established, profitable, and expanding Contract Development and Manufacturing Company (CDMO) with operations based in the US, Canada and Europe (note: the USA HQ for this CDMO is based in the NJ/PA area, and this position can be remotely based from home).

You will work closely with Sr. Management in this highly visible Regulatory Affairs Strategy and Leadership position. You will lead, direct, manage, mentor, and develop/expand a team of ~9 Regulatory Affairs professionals based in the US and in the EU. You will make significant contributions that will influence and impact the Regulatory Affairs strategies and filings for this Specialty CDMO’s proprietary and complex branded, generic and OTC products.

LOCATION: Executive Director position can be based remotely from home, or it can be based in the US HQ in the NJ/PA area


  • Visibility: the top Regulatory Affairs professional working closely with Sr. Management, reporting to the CSO
  • Impact: plenty of opportunity to make significant contributions in this top GRA role
  • Scope: global responsibility for current & new products: Co already markets >40 products in >100 countries
  • Lead & manage direct and develop a team of ~9 based (direct & indirect reports) based in the US and EU
  • Build: expand your staff/team as needed in the US and EU
  • Compensation & benefits package: receive an attractive package including a 7% 401k Company contribution
  • Opportunity to join a very successful Company: this is a very attractive opportunity to join a well-established (25+ years), very successful Specialty CDMO that continues to grow and expand, and continually develops and acquires new, better, and novel technologies to add to its multiple proprietary dosing formulations and drug delivery capabilities
  • Opportunity to join a CDMO with unique and proprietary drug formulation and drug delivery capabilities for patients, especially underserved patient populations


  • Education: Advanced degree is a plus, but not required
  • 10+ years of progressive Regulatory Affairs experience
  • Regulatory strategies and filings for CMC and BA/BE aspects of product filings, and ANDA and 505(b)(2) filings
  • Strong knowledge of US and Global Markets regulatory requirements, especially CMC requirements
  • Strong communication skills; strong oral, writing and presentation skills
  • Management experience: direct and/or project management/leadership management experience

CONFIDENTIALITY:  All communications are treated as highly confidential information.


Courtland T. Miras | Senior Director

E: ctmiras@cornerstonesg.com

P: 973-656-0220 x737

LinkedIn: linkedin.com/in/courtlandmiras


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

Six Campus Drive | Suite 301 | Parsippany, New Jersey 07054 USA


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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