Principal Consultant - Regulatory Development

Boston (Remote Option Available)
 

The Principal Consultant, Regulatory Development will serve as a regulatory expert to our clients and will be responsible for leading and/or providing technical consulting for our development stage engagements. The successful candidate will have a proven record of regulatory development strategy, leadership, and execution within biotech, pharmaceutical and/or device companies and will bring exceptional interpersonal communication skills and a flexible approach. Typical experience includes 16-20+ years of industry experience with extensive experience leading multiple regulatory projects and/or programs.  

Job Responsibilities
  • Develop and advise on regulatory strategies to guide biotech, pharma, and/or device companies through development decisions
  • Act as an on-demand Director/VP/Head of Regulatory to multiple sponsor companies, bringing real-world experience and an ability to roll up your sleeves and get the work done
  • Lead regulatory teams and activities focusing on pre-IND activities, planning global development programs, IND strategies and submissions, meetings with the Agency, special designations, and other regulatory submissions and meetings
  • Work efficiently and collaboratively with sponsor C-level team members, sponsor development team members, and internal Halloran team members
  • Partner with drug development companies to understand their company objectives and goals; develop and implement regulatory strategies to help them reach those goals
  • Actively manage a small group of direct reports to ensure their development and growth 
  • Actively market Halloran’s services by networking, identifying leads, participating in industry working groups, writing papers and presenting at conferences on innovative approaches to early drug development
  • Act as a thought leader and face of the company in certain segments of work
  • 25% travel, highly varied
  • 75%= billable utilization
Education and Experience Requirements
  • Bachelor’s Degree in a related field
  • Advanced degree in life science- MD, PhD, PharmD, etc.
  • Experience in oncology, immune-oncology, and/or cell/gene therapy is a plus
  • 16-20+ years of regulatory work experience in a biotech or pharmaceutical settings across both small and mid-to-large biopharma companies 
  • Regulatory interaction experience with US; experience with ex-US Health Authorities is a plus
  • Familiarity with current regulatory legislation, industry trends, and health care / business practices in drug development
  • Leadership experience
Characteristics of Top Performers
  • Excellent communication and presentation skills 
  • High energy and relentless passion to improve human health
  • Ability to work with multiple companies on multiple programs
  • Ability to lead independently with exceptional organization and attention to detail
  • Big-picture thinker with an ability to drive the details when necessary
  • Comfortable with ambiguity and high-pressure situations
  • Flexible and able to adjust/change course based on data, feedback, client request, etc.
  • Successful collaborator with clients and internal management and an ability to coach team members  
Halloran Consulting Group | Principal Consultant Regulatory Development