Global Regulatory Affairs Strategy Lead

3 weeks ago


Reston, Virginia, United States Cornerstone Search Group Full time

Director, Global Regulatory Affairs Strategy Lead - Oncology


CORNERSTONE SEARCH GROUP is proud to be retained again by a highly successful, $1.5Bn+ pharma with a unique and positive work environment that perfectly reflects its country's renowned culture. This company boasts a dynamic product portfolio featuring a current oncology blockbuster that is still on the rise and the upcoming launch of another anticipated oncology blockbuster. We are seeking a highly experienced and entrepreneurial oncology regulatory affairs professional who is passionate about drug development and values working with like-minded high EQ individuals in a collaborative and low-bureaucracy environment.


5 ATTRACTIVE FEATURES:


(1) Unique opportunity to join a growing, profitable, publicly-traded company with a $7Bn market cap that still retains a small company feel with very few layers.


(2) The company's marketed products include a fast-growing cancer blockbuster, and their lead clinical candidate is in Phase III and is anticipated to also become a blockbuster.


(3) This company takes pride in its home country's reputation as one of the world's happiest countries.


(4) We have partnered with this client multiple times before, so we know them quite well. The people that we have helped them hire have been very happy with the culture and impressed with executive management and their peers.


RESPONSIBILITIES:



  • Develop and execute US and Global regulatory submission strategy for oncology assets, featuring a lead asset with first-in-pathway/first-in-class potential.
  • Interact with the FDA and global regulatory authorities.
  • Take responsibility for the preparation and content of US and global regulatory dossiers/documents (e.g., INDs, CTAs, BRD/Scientific Advice Requests, and NDAs/MAAs).
  • Ensure that product development programs are aligned with US and global commercial strategy.
  • In addition to the company's wholly owned assets, interact with other pharmas on JV-partnered assets.
  • Lead internal company forums for the sharing of best practices and lessons learned.
  • Stay on top of emerging issues that may impact regulatory product strategy and adjust accordingly.

DESIRED SKILLS/ QUALIFICATIONS / EXPERIENCES / BEHAVIORS:



  • 3-7 years of pharma/biotech oncology regulatory affairs experience with demonstrated experience defining and leading clinical-stage regulatory strategy.
  • IND filing experience and ideally also NDA/BLA filing experience.
  • In-depth working experience of US regulatory affairs, including FDA interaction experience, coupled with an understanding of EU, ICH, and other global requirements.
  • Experience with preparing, reviewing, and submitting FDA Clinical modules. CMC and Nonclinical module experience would be a plus.
  • Operational experience with regulatory submissions to the FDA (e.g., INDs and NDAs). It would be a plus, but not a requirement, to have EU submission experience (e.g., CTAs and MAAs) or other global regulatory submission experience.
  • Experience with novel or expedited regulatory pathways would be a plus but is not required.

Cornerstone Search Group is a Life Sciences Executive Search firm that helps companies find, attract, and hire talent for their US and globally based leadership positions (CxO and xVP levels) as well as their critical Director-level roles. We are recognized by Forbes as one of the Top 100 Executive Search Firms and by Hunt Scanlon as one of the Top 50 Healthcare & Life Sciences Executive Search Firms. Our representative retained search assignments include:



  • CEO | specialty pharma start-up
  • CEO | regenerative medicine start-up
  • US CEO | established European small pharma
  • President/US Commercial Head | generics pharma
  • CMO | late-stage public biotech
  • CMO | mid-size pharma
  • CSO | mid-size global biotech
  • SVP, Head of Global Medical Affairs | mid-size oncology company
  • SVP, Head of Global Clinical Development | multi-TA mid-size pharma
  • SVP, Head of Global Regulatory Affairs | late-stage Israeli biotech


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