Principal Consultant, Regulatory Affairs/Regulatory CMC

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 Principal Consultant to join its Regulatory Affairs practice area. In this role, you will serve as a regulatory expert in either the areas of Regulatory Development or Regulatory CMC to our clients and will be responsible for leading and/or providing technical consulting for our development stage engagements, while also leading and mentoring a small team of consultants. 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. 

Role 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 health authorities, special designations, and other regulatory submissions and meetings to progress an asset through the development process
  • Work efficiently and collaboratively with client C-level team members, client 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 Halloran  
  • 25% travel, highly varied
  • 75% billable utilization
Education and Experience Requirements
  • Bachelor’s Degree in a related field
  • Advanced degree in life science is a plus
  • For Regulatory Development experts, experience in oncology is a plus
  • For Regulatory CMC experts, experience in multiple product types is a plus
  • Experience in cell/gene therapy and other innovative development trends 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
  • The successful candidate will have a history of progressive leadership experience and roles
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 independently lead 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 requests, etc.
  • Successful collaborator with clients and internal management and an ability and desire to coach team members  
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
Halloran Consulting Group | Principal Consultant, Regulatory Affairs Regulatory CMC