Lead Consultant, Regulatory CMC (Biologics)
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? Join Halloran’s Regulatory team as a Lead Consultant, Regulatory CMC (Biologics) today!
In this role, you will manage multiple Regulatory programs for development stage pharmaceutical 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.
- Serve as a regulatory and/or project lead for multiple pharmaceutical company engagements, guiding, developing, and advising for multiple indications and product types in all stages of development focusing on Regulatory CMC activities
- 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, CMC sections investigational and commercial submissions, and other regulatory documents
- Lead and/or conduct direct interactions with Health Authorities by phone and email correspondence
- 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, 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 in a science field with at least ten years of combined CMC and Regulatory Affairs experience in a pharmaceutical setting
- Experience leading Regulatory CMC strategic activities across all phases of development
- Experience interacting with FDA
- 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 Education and/or Certifications
- Prior Consulting experience
- Regulatory interaction experience with ex-US Authorities
- Experience with multiple product types (small molecules, biologics, etc.)
The targeted gross compensation range for this position is between $120,000.00 and $175,000.00 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.
Halloran Consulting Group, Inc. COVID-19 Considerations:
Successful applicants for employment must provide proof of full COVID-19 vaccination as a condition of entering Halloran’s offices, attending Halloran sponsored events (at Halloran offices or otherwise), and traveling to client sites, subject to requests for accommodation. Individuals will be considered fully vaccinated two weeks after a second shot of a two-shot vaccine regimen (i.e., Pfizer or Moderna) or two weeks after a single shot of the Johnson & Johnson vaccine.
Halloran does not sponsor visas for employees.
All remote employees are expected to have a consistent home internet connection with speeds of at least 25Mbps while working remotely.
Halloran Consulting Group, Inc. is an equal opportunity employer committed to diversity, equity and inclusion in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local nondiscrimination laws).
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.