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Senior Associate – Regulatory Affairs (CMC) at ClinChoice - ApplyBlast

Senior Associate – Regulatory Affairs (CMC)

ClinChoice

4 months ago

3.3 on Glassdoor

Bengaluru, India

Onsite

Full Time

Senior

0 applicants

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About this role

A Regulatory Affairs professional manages the preparation and submission of new product registrations and post-approval filings for herbal products. The role involves developing regulatory strategies, ensuring compliance with local and regional health authorities, and coordinating product life cycle management. Key duties include writing CMC modules, preparing Product Quality Reviews, and compiling labeling components according to standard operating procedures.

Responsibilities

Manage preparation and submission of new product registrations
Develop and execute regulatory strategies for local and regional markets
Write CMC modules and prepare Product Quality Reviews
Ensure regulatory compliance with local health authority requirements
Coordinate product life cycle management and labeling compliance

Skills

Qualifications

Bachelor's degree in Life ScienceMaster's degree in PharmaRAPS certification

About ClinChoice

clinchoice.com

Headquarters

Horsham, Pennsylvania, United States

Company Size

1001-5000 employees

Founded

1995

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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.