Lead Consultant / Consultant, Regulatory Development

Boston - Remote within U.S. Option Available

 

We are looking for an experienced regulatory development consultant to join our expanding regulatory team. This position will guide clients through decisions regarding regulatory development strategies and submissions. A successful candidate will bring exceptional interpersonal communication, a flexible attitude, and a proven record in regulatory interactions with global Health Authorities.

Job Responsibilities

  • Partner with development stage biotech, pharmaceutical, and device companies to guide, develop, and advise on regulatory development strategies and submissions
  • Act as a regulatory lead and/or project or program leader for multiple biotech, pharma, and/or medical device company engagements
  • Lead regulatory teams and activities focusing on pre-IND guidance, planning global development programs, IND strategies and submissions, meetings with Health Authorities, special designations, and other regulatory submissions 
  • Lead and manage interactions with regulatory agencies and associated submissions 
  • Author meeting documents, INDs, special designation requests, and other regulatory submissions
  • Ensure consistent high-quality delivery of client deliverables and goals by working collaboratively with client executives and team members and internal Halloran team members (regulatory operations, clinical, program management, etc.); ensure projects are delivered on time and within budget
  • Up to 15% travel to the Boston office 

Education and Experience Requirements

  • Bachelor’s Degree in a science field is preferred
  • A Master’s Degree and/or regulatory certifications are a plus 
  • Experience in oncology, immuno-oncology, neurology, and/or cell/gene therapy 
  • Medical device experience is a plus
  • 8-12+ years’ work experience in a biotech, pharmaceutical and/or healthcare industry across both small and mid-to-large biopharma companies 
  • Regulatory interaction experience with US  and ex-US Authorities 
  • Deep familiarity with current regulatory guidance, good clinical practice, legislation, industry trends, health care / business practices in drug development  

Characteristics of Top Performers

  • High energy and relentless passion to improve human health
  • Excellent interpersonal communication and presentation skills 
  • Ability to work with multiple companies on multiple programs
  • Ability to lead independently with exceptional organization and attention to detail
  • Action-oriented, independent and ready for responsibility
  • Successful collaborator with clients and internal management 

 

Consultant or Lead Consultant - Regulatory Development | Halloran Consulting Group