ClinChoice
The Regulatory CMC Technical Lead Consultant is responsible for managing and creating CMC regulatory documents to support global submissions to regulatory authorities. This role involves advising multidisciplinary teams on regulatory requirements, negotiating strategies with agencies, and representing the company during GMP inspections. The position requires a deep understanding of global CMC regulations and experience in small molecule drug development, with biologics and ADCs being a strong advantage.
Headquarters
Horsham, Pennsylvania, United States
Company Size
1001-5000 employees
Founded
1995
ClinChoice is a full‑service global contract research organization (CRO) that helps accelerate drug and medical device approvals to market. They offer end‑to‑end clinical development, regulatory strategy, and operational support across study design, execution, data management and safety to guide sponsors through all phases of development. With global site networks, therapeutic expertise and data‑driven processes, ClinChoice aims to shorten timelines and reduce risk for development programs. They partner with biotech, pharma and device companies to navigate complex regulatory pathways and bring safer products to patients.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
View leadership team, funding history,
and employee contacts for ClinChoice.
ClinChoice didn’t post a salary, so this is our estimate from similar listings.
8% above the average for this role
ClinChoice Opens International Headquarters In Horsham
Dec 26, 2024
Regulatory Affairs Consultant CMC Author
Parexel
Regulatory Affairs Consultant, CMC – Biologics
Parexel
Manager Regulatory Affairs-CMC
Integrated Resources INC
Director, Regulatory CMC
Acadia Pharmaceuticals Inc.
Regulatory CMC Lead
Eli Lilly and Company
Associate Director, Regulatory Affairs, CMC- Biologics
alnylam