ClinChoice, a global clinical research and regulatory solutions organization, is hiring a Senior Associate โ CMC Regulatory Affairs for its Bengaluru, India location. This opportunity is ideal for professionals with hands-on experience in CMC regulatory submissions, eCTD documentation, and EU & CIS regulatory filings.
The role focuses on CMC Modules 2 and 3, product lifecycle management, and regulatory strategy execution to support new product registrations and post-approval submissions. Candidates with strong regulatory writing skills and familiarity with EU pharmaceutical guidelines will find this position highly rewarding.
Key Responsibilities โ Senior Associate CMC Regulatory Affairs
- Prepare, review, and submit new product registrations and post-approval submissions
- Author and review CMC Modules 2 & 3 as per global regulatory standards
- Handle EU and CIS regulatory filings, including agency queries and approvals
- Manage product lifecycle management (PLCM) activities
- Ensure compliance with local and international regulatory requirements
- Coordinate with internal stakeholders and maintain liaison with health authorities
- Provide regulatory support for new product launches, line extensions, and tenders
- Maintain regulatory tracking tools to improve transparency and performance
- Support regulatory intelligence initiatives at local and regional levels
- Execute regulatory strategies aligned with business plans
- Review formulations, ingredient lists, claims, and labeling components as per SOPs
- Ensure adherence to timelines, quality standards, and regulatory commitments
Qualifications & Skills Required
- Bachelorโs degree (B.S.) in Chemistry, Pharmacy, or 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
Why Join ClinChoice?
- Work with a global regulatory and clinical research organization
- Exposure to international regulatory submissions (EU & CIS)
- Opportunity to strengthen expertise in CMC regulatory strategy
- Collaborative, quality-driven professional environment
- Career growth in regulatory affairs and pharmaceutical compliance
Job Location
Bengaluru, Karnataka, India
Estimated Salary (India)
๐ฐ โน8,00,000 โ โน14,00,000 per annum (based on experience and regulatory exposure)
How to Apply
