Lead Consultant/Consultant, Regulatory Development

Boston - Remote within U.S. Option Available

 

Are you looking for a company that is committed to improving human health, and a role that will develop and challenge you to think innovatively and push beyond the status quo? Join Halloran Consulting Group, Inc. today!

Halloran is looking for a Lead Consultant/Consultant, Regulatory Development to join its Regulatory Affairs practice area. In this role, you 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.

Role 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
Halloran Consulting Group, Inc. Perks:
  • Comprehensive Medical, Dental, and Vision Insurance
  • 401(k) Plan for all Full-Time Employees
  • Commuter Benefits
  • Reimbursements for Health & Wellness Programs and Memberships
  • Self-Managed Vacation Policy
Lead Consultant/Consultant, Regulatory Development | Halloran Consulting Group