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Lead Consultant, Regulatory CMC (Cell & Gene Therapy)

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 today!

The Role You’ll Play:

With Halloran’s “sweet spot” being the small to medium sized life science sponsor companies, we routinely work with clients developing innovative products to meet unmet patient needs. A significant portion of these products are Cell and Gene Therapies, and we need an additional Regulatory CMC professional to help us to continue to take on this work and make a significant contribution to the betterment of human health.

Our clients are at various phases of development, both in terms of their products and their organizations. Your combination of technical understanding of CMC components of regenerative medicines and the Regulatory considerations needed to achieve successful approval will allow you to play multiple roles with our clients. Our resourcing model gives you the opportunity to take on multiple projects at once, which can have you doing anything from being a key part of IND and BLA teams to serving as an interim resource or advisor to clients looking to supplement the knowledge and expertise of their internal Regulatory teams.

This opportunity will also give you the opportunity to share the insights you will glean from working on some of the most groundbreaking developments in personalized medicine across multiple companies simultaneously. Halloran’s cultivated ecosystem of publications, alliances, and working groups will give you the opportunity to share these perspectives in multiple settings, showcasing your expertise as a Regulatory CMC expert. The internal enthusiasm at Halloran for these topics is also high; you’ll have the opportunity to coach and mentor talent here looking to build their own acumen in this space, helping to build our collective acumen and allowing us to continue to improve human health and shift the life science industry.

What We’re Looking For:

With a bustling pipeline of work, we’re looking for someone to quickly embed themselves with our clients and make an impact with their technical expertise. We’re looking for someone who has experience working as a Regulatory CMC professional in the Cell and Gene Therapy space, being a key contributor to the development of these products. Someone who understands how to interact with FDA, from both a formal meeting and written submissions perspective, and how to balance the development of these products with an appropriate level of risk will be able to immediately make a significant impact at Halloran and the clients and team members who eagerly await your expertise.

Compensation:

The targeted gross compensation range for this position is between $130,000.00 and $180,000.00 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.

Notice:

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.

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