Principal Consultant, Regulatory

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.

Characteristic Duties:
  • 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
Qualifications:

Required:

  • Bachelor’s Degree in a related field and a minimum of 16 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
  • Familiarity with current regulatory legislation, industry trends, and health care / business practices in drug development
  • History of progressive leadership experience and roles

Preferred:

  • Advanced degree in life science
  • For Regulatory Development experts, experience in oncology
  • For Regulatory CMC experts, experience in multiple product types
  • Experience in cell/gene therapy and other innovative development trends
  • Experience with ex-US Health Authorities
Halloran Consulting Group, Inc. Perks:
  • Comprehensive Medical, Dental, and Vision Insurance
  • 401(k) Plan for all Full-Time Employees
  • Reimbursements for Health & Wellness Programs and Memberships
  • Opportunities for Internal and External Learning through Conference Attendance and Tuition Reimbursement
  • Self-Managed PTO Policy
  • Commuter FSA Benefits

 

Notice:

Our company is committed to equal employment opportunity.  We will not discriminate against employees or applicants for employment based on any protected class including, but not limited to race, color, religious creed, national origin, sex, pregnancy, sexual orientation, ancestry, age [over 40], veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.

 

Halloran Consulting Group | Principal Consultant, Regulatory