Lead Consultant, Regulatory Affairs
Are you looking for a company committed to improving human health, and a role that will develop and challenge you to think innovatively? Join Halloran’s Regulatory Affairs team as a Lead Consultant, Regulatory Affairs today!
In this role, you will run multiple Regulatory programs for biotechnology, pharmaceutical, and medical device companies, strategizing and executing on various Regulatory Agency submissions. You will support and guide clients on activities spanning from pre-IND through market approval and ensure consistent high-quality client results.
- Serve as a regulatory and/or project lead for multiple biotechnology, pharmaceutical, and/or medical device company engagements, guiding, developing, and advising for multiple indications and product types in all stages of development
- Contribute to strategic development planning and support to emerging life science companies pursuing early to late stage development
- Coordinate, lead, author, and/or review regulatory assessments, integrated development plans, Health Authority meeting documents, special designation requests, investigational and commercial submissions, and other regulatory documents
- Lead and/or conduct direct interactions with Health Authorities by phone and email correspondence, serving as Authorized Sponsor Representative to the FDA on behalf of clients
- Establish project scope, expectations, plan, and details that ensure high quality, timely and in budget results
- Supervise, analyze, and report project status, utilizing appropriate communication methods to update and solicit approval from internal and client partners
- Identify, mitigate and analyze the impact of any project risks, supporting timely resolution and client-facing response
- Educate existing and potential clients on Halloran services and opportunities for partnerships, authoring proposals and statements of work
- Participate in internal activities such as invoicing, bookings, developing new product offerings and consulting services
- Showcase your subject-matter expertise, serving on internal process optimization activities and speaking publicly at conferences and workshops
- Mentor and lead internal Halloran team members to ensure success of company and client goals, in direct management, project-based, or matrixed relationships
- Other duties and responsibilities as assigned
- Bachelor’s Degree and a minimum of ten years in a biotechnology or pharmaceutical setting
- A proven track record leading Regulatory strategy and submissions activities, including participating in Health Authority interactions
- Familiarity with current regulatory guidance, good quality practices (GxPs), legislation, and industry trends
- Ability to work creatively and analytically to balance multiple priorities, tasks, and sophisticated issues using logical and efficient processes
- Exercise good judgment in selection methods, techniques and evaluation criteria for sophisticated, complex issues that may require in-depth evaluation of variable factors
- Advanced Degrees and/or Certifications
- Experience in a Consulting setting
- Experience in oncology, Immuno-oncology, cell and/or gene therapy
- Experience with multiple product types (small molecules, biologics, etc.)
The targeted gross compensation range for this position is between $135,000.00 and $170,000.00 annually. Please note: this compensation range is Halloran’s good-faith and reasonable estimate of the range of possible compensation for this particular position at the time of posting; however, Halloran may ultimately pay more or less than the posted range.
Halloran Benefits and Perks:
The benefits of being a Halloran employee go beyond the unparalleled opportunities of your day to day work! We offer an annual, discretionary bonus based on company and individual performance, comprehensive Medical, Dental, and Vision Insurance, and a 401(k) Plan for all full-time employees. We offer reimbursements for Health & Wellness Programs and Memberships, opportunities for continued learning through conference and continuing education programs. We also offer a Self-Managed PTO Policy, Commuter FSA Benefits, and many other benefits.
We are committed to equal employment opportunities for all applicants and employees. We do 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, veteran status, genetic information, disability, gender identity and expression, citizenship status, handicap, military membership or any other legally-protected characteristic.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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 an authorized representative of Halloran.