Regulatory Scientist

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Full-time

Regulatory Scientist

VCLS

Somerville, new jersey

About VCLS

Are you a passionate regulatory professional eager to make a difference in the healthcare landscape? At VCLS (formerly B&H Consulting Services), we are a team dedicated to providing exceptional support for our clients' regulatory needs.

We offer a comprehensive suite of services, from crafting winning regulatory strategies to managing electronic submissions and expertly coaching clients for successful FDA meetings. Our diverse client base includes leading pharmaceutical corporations, alongside innovative biotech startups.

The Opportunity:

Join our dynamic team as a Regulatory Scientist and make a real impact in shaping the future of life-changing therapies. This hybrid role offers the flexibility of in-office and remote work, allowing you to thrive in a collaborative environment while maintaining a healthy work-life balance.

What You’ll Do:

Regulatory Strategy:...

Full-time
Regulatory Scientist
Orchard Therapeutics
Boston, massachusetts
Location: London, UK (or Boston, US)
Reporting to: Director, Regulatory Science Early-Stage Programs

Job Summary
This role will report to the Director, Regulatory Science for Early-Stage programs. The successful candidate will have the opportunity to primarily work with Global and Regional Regulatory Leads who are responsible to develop the regulatory strategy and prepare high quality global regulatory submissions for early-stage development programs.
Early-stage programs encompass all Orchard Therapeutics ex vivo gene therapy assets from preclinical stage up to clinical Phase 3/registrational study development. After initiation of the registrational clinical study, programs evolve to the late-stage status.
This position may also provide...

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