Lead Consultant, Regulatory Affairs
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 to join its Regulatory Affairs practice area. As a Lead Consultant, you will manage multiple Regulatory programs for development stage biotech, pharmaceutical, and device companies to guide, develop, and advise on regulatory development strategies and submissions. You will support and guide clients on activities spanning from pre-IND through market approval and ensure consistent high-quality client deliverables.
- Act as a regulatory lead and/or project leader for multiple biotech, pharma, and/or medical device company engagements; participate in cross-functional regulatory programs in a variety of indications and product types in all stages of development
- Work with development stage biotech, pharmaceutical, and device companies to guide, develop, and advise on regulatory development strategies and submissions
- Contribute to strategic development planning and support to emerging life science companies pursuing early to late stage development; contribute to regulatory assessments, integrated development plans, and other strategic planning documents to drive development of clients' assets and platform technologies
- Coordinate, manage, author, and/or review Health Authority meeting documents, special designation requests, and other regulatory submissions
- Lead and/or conduct direct interactions with Health Authorities by phone and email correspondence
- Coordinate, author, manage, and review sections of investigational and commercial submissions to Health Authorities.
- Ensure consistent high-quality delivery of client deliverables and goals by working collaboratively with client team members and internal Halloran team members (regulatory operations, clinical, project management, etc.); ensure projects are delivered on time and within budget
- Serve as Authorized Sponsor Representative to the FDA on behalf of clients
- Provide guidance to clients by maintaining knowledge of current regulatory landscape including Health Authority regulations, guidance, and directives
- Effective client management, including assessing and ensuring client satisfaction as well as current and future needs of the client development team; administrative client management tasks such as invoicing, bookings, etc.
- Mentor internal Halloran team members (up, down, and across the organization) to ensure success of company and client goals
- Contribute to business development efforts, including the authoring of proposals for new client engagements
- Other duties and responsibilities as assigned
- Bachelor’s degree in a life science related field with at least ten years of experience in a biotech or pharma setting
- Regulatory interaction experience with US and ex-US Authorities
- Deep familiarity with current regulatory guidance, GxPs, legislation, industry trends, and health care/business practices in drug development
- Experience supporting program level strategic planning activities spanning from pre-IND through marketing approval
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
Our company is committed to equal employment opportunities for all applicants and employees. 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.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
No agencies please; please note that no agency can claim ownership over a candidate without a written agreement in place with Halloran signed by a member of Halloran’s Human Resources or Talent Acquisition teams.