Executive Director | Global Regulatory Affairs (GRA) | Top GRA Role | Expanding CDMO | Remote Based: RETAINED SEARCH

Cornerstone Search Group
Published
April 5, 2021
Location
REMOTE, Greater New York City Area, United States of America
Category
Job Code
cmNH2816csg
Contact Email
cmiras@cornerstonesg.com

Description

Executive Director |Global Regulatory Affairs (GRA) | Top GRA Role | Expanding CDMO | Remote Based: RETAINED SEARCH

SUMMARY:

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 GRA Strategy and Leadership position. You will lead, direct, manage, mentor, and develop 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

ATTRACTIVE FEATURES INCLUDE (AMONG OTHERS):

  • Visibility: this is the Top GRA professional working closely with Sr. Management
  • 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 a competitive 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

QUALIFICATIONS/REQUIREMENTS:

  • Education: BA/BS an 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.

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 | 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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