Senior Associate CMC Regulatory Affairs job in Bengaluru at ClinChoice for EU and CIS filings, Module 2 and 3 eCTD submissions.
CMC Regulatory Affairs Job in ClinChoice
Job Type: Full-Time
Industry: Pharmaceutical / Regulatory Affairs
Functional Area: CMC Regulatory Affairs
Job Location: Bengaluru, Karnataka, India
Application Mode: Online
Job Status: Verified Job
Job Overview
ClinChoice, a global clinical research and regulatory solutions organization, is hiring a Senior Associate – CMC Regulatory Affairs for its Bengaluru location. Senior Associate CMC Regulatory Affairs job in Bengaluru
This role is ideal for professionals with hands-on experience in CMC regulatory submissions, eCTD documentation, and EU & CIS regulatory filings. The position focuses on CMC Modules 2 and 3, product lifecycle management, and execution of regulatory strategies supporting new product registrations and post-approval submissions. Senior Associate CMC Regulatory Affairs job in Bengaluru
Job Title
Senior Associate – CMC Regulatory Affairs
Key Responsibilities – Senior Associate CMC Regulatory Affairs
- Prepare, review, and submit new product registrations and post-approval regulatory submissions
- Author and review CMC Modules 2 and 3 in accordance with global regulatory standards
- Manage EU and CIS regulatory filings, including authority queries and approval follow-ups
- Handle product lifecycle management (PLCM) activities
- Ensure compliance with local and international regulatory requirements
- Coordinate with internal cross-functional teams and maintain liaison with health authorities
- Provide regulatory support for new product launches, line extensions, and tender applications
- Maintain regulatory tracking systems to enhance transparency and performance
- Support regulatory intelligence initiatives at local and regional levels
- Execute regulatory strategies aligned with defined business plans
- Review formulations, ingredient lists, product claims, and labeling components as per SOPs
- Ensure adherence to regulatory timelines, quality standards, and compliance commitments
Senior Associate CMC Regulatory Affairs job in Bengaluru
Qualifications & Skills Required
- Bachelor’s degree in Chemistry, Pharmacy, or a related scientific discipline
- Proven experience in CMC Regulatory Affairs for pharmaceutical products
- Strong exposure to Module 3, Module 2.3, and Module 1 eCTD documentation
- Sound understanding of EU pharmaceutical regulations and guidelines
- Excellent written and verbal communication skills
- Strong project management and multitasking abilities
- High attention to detail and ability to work independently
Senior Associate CMC Regulatory Affairs job in Bengaluru
Why Join ClinChoice?
- Work with a globally recognized regulatory and clinical research organization
- Gain exposure to international regulatory submissions (EU & CIS regions)
- Strengthen expertise in CMC regulatory strategy and lifecycle management
- Collaborative, quality-driven professional environment
- Long-term career growth in regulatory affairs and pharmaceutical compliance
Estimated Salary (India)
₹8,00,000 – ₹14,00,000 per annum
(Salary depends on experience, skill set, and regulatory exposure)
How to Apply
Interested candidates can apply online through the official application link provided by ClinChoice. Senior Associate CMC Regulatory Affairs job in Bengaluru
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