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.
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
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; 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
Reimbursements for Health & Wellness Programs and Memberships
Self-Managed Vacation Policy
Telecommuting is allowed.
Additional Salary Information: This position comes with a salary, bonus structure, and full benefits as a Halloran employee.
Internal Number: 109
About Halloran Consulting Group, Inc.
In life science, every new drug or medical device springs from the drive to improve human health. In 1998, Laurie Halloran realized that the life science companies she worked with needed senior-level expertise to navigate the regulatory, clinical, and operational challenges facing each stage of development.
Halloran Consulting Group, with a growing team of industry experts, can help you find a solution.