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Regulatory Affairs CMC Consultant at ClinChoice - ApplyBlast

Regulatory Affairs CMC Consultant

ClinChoice

1 month ago

3.3 on Glassdoor

United States

Onsite

Contract

Senior

0 applicants

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About this role

ClinChoice is seeking an experienced Regulatory CMC Consultant for a 12-month contract to support a client's pharmaceutical and self-care portfolio. The role involves providing regulatory CMC expertise across new product development, lifecycle management, and global regulatory submissions. The consultant will partner with cross-functional teams to develop effective CMC regulatory strategies and ensure compliance.

Responsibilities

Lead regulatory CMC strategy for new product development and lifecycle management programs
Develop and review CTD Module 2.3 and Module 3 documentation for global regulatory submissions
Assess proposed CMC changes for regulatory impact, compliance, risks, and submission requirements

Skills

About ClinChoice

clinchoice.com

Headquarters

Horsham, Pennsylvania, United States

Company Size

1001-5000 employees

Founded

1995

View Profile

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.