Director, Regulatory Affairs (IND/NDA/MAA) – NC BioPharma – Direct Hire - Homebased

Job Type: 
Life Sciences
Other Life Science Positions
Professional Services
Other Professional Positions
Employment Category: 
Direct Hire

Our client, a rapidly-expanding Biopharma company in Research Triangle Park, NC, is actively recruiting for a highly skilled Regulatory Affairs leader to assume a key role on its R&D team.  Company will pay top dollar to attract and retain an excellent candidate.

This company is publicly-held, is focused on the oncology space and has numerous compounds in development.  It is an exciting time and we seek an exceedingly capable Regulatory Affairs Director to develop, lead, and direct global regulatory strategies for its clinical-stage oncology programs – both within the US and EU.  Experience driving INDs, NDAs and MAAs will be essential. 

Key Things to Note:

  • This is a home-based role
  • Near-term focus will be leading global regulatory strategy.  Familiarity with US and EU requirements will be important
  • This Director will drive IND, NDA and MAA processes.  Expert knowledge of submission requirements and processes will be essential.
  • Company uses third party vendors for key functions.  Experience overseeing external parties is required
  • This Director will be responsible for overseeing and assisting in the preparation and review of responses to health authorities.  Experience interacting with Regulatory authorities will be important.

The focus of this role will be to develop, lead, and direct global regulatory strategies for clinical-stage oncology programs. 

Specific duties will include:

  • Develop, lead, and direct global regulatory strategies for clinical-stage oncology programs
  • Lead preparation of regulatory documents, including INDs, NDAs and MAAs
  • Lead and represent the company in regulatory health authority meetings
  • Oversee and assist in the preparation and review of responses to health authorities
  • Lead IND and NDA maintenance to support all clinical development activities
  • Ensure adherence to relevant regulatory guidance and regulations.

This is an emerging environment and employees are hands-on, flexible and mission-driven.  We seek a candidate whose industry credentials are complemented by the versatility, resourcefulness and commitment to thrive.

Requirements include a Bachelor’s degree in a scientific field (advanced degree, PharmD, PhD, MS, preferred) and 10+ years of increasingly responsible roles in Regulatory Affairs, including substantial experience with global submissions (US and EU)

Other priorities include:

  • Experience developing and leading regulatory strategies for INDs, CTAs, NDAs, and/or MAAs.
  • Substantial knowledge and understanding of drug development and regulatory requirements, US and EU with regard to submission content and format
  • Exceptional project leadership skills including demonstrated ability to manage complex timelines in a fast-paced team environment
  • Ability to make decisions, think critically, solve problems and respond proactively.

This position has great potential.  We seek a natural point person and one who can have great impact. Longevity, upward mobility and record of impact in previous positions will all be important.

Please forward Word resume for prompt consideration.