Regulatory Consultant (CMC – EU/Japan/China)
Location: Gurugram, India (Hybrid Work Model)
Company: Syneos Health
Experience Level: Mid to Senior
Job Type: Full-time
Salary Range: Not disclosed
Job Summary
Syneos Health is seeking a Regulatory Consultant (CMC – EU/Japan/China) to join its global regulatory affairs team. This hybrid role based in Gurugram, India is ideal for professionals with hands-on experience in drug product CMC submissions, global product registration, and lifecycle management. You’ll play a key role in ensuring regulatory compliance across major international markets, including the EU, Japan, and China.
This is an excellent opportunity to be part of a cross-functional, collaborative environment that values innovation, technical expertise, and proactive client engagement.
Key Responsibilities
Conduct regulatory research and gap analyses for global and regional submissions
Prepare CMC components of INDs, NDAs, pre-approval packages, and post-approval filings
Prepare briefing packages and support regulatory authority interactions
Manage regulatory project timelines, deliverables, and client expectations
Provide subject matter expertise for troubleshooting and team mentoring
Support proposal development and client business meetings
Ensure regulatory compliance with local and global standards
Contribute to SOP creation, training documentation, and audit readiness
Provide guidance to team members and escalate issues to senior leadership as needed
Required Skills & Qualifications
Master’s degree in Pharmacy, Science, or a related healthcare field
Hands-on experience in Drug Product CMC submissions across EU/Japan/China markets
In-depth knowledge of global regulatory guidelines and procedures
Strong communication, project management, and problem-solving skills
Proficiency in Microsoft Office and regulatory software tools
Ability to handle multiple regulatory projects independently
Prior experience in cross-functional and client-facing environments
Fluency in English (written and verbal)
Perks & Benefits
Hybrid work flexibility (Gurugram location)
Career development and technical training opportunities
Recognition and rewards for high performance
Collaborative, inclusive, and diverse team environment
Exposure to global pharmaceutical regulations and markets
Participation in impactful regulatory strategy projects
About Syneos Health
Syneos Health is a global biopharmaceutical solutions organization that accelerates the delivery of therapies to market. With involvement in over 94% of FDA-approved novel drugs and 95% of EMA-authorized products, Syneos Health brings together clinical, medical affairs, and commercial capabilities to improve healthcare outcomes worldwide.
Work Mode: Hybrid (Gurugram, India)
Location: IND-Gurugram-Hybrid
Job ID: 25100126
Ready to Shape the Future of Global Drug Development?
Join Syneos Health’s regulatory affairs team and make your mark on global healthcare compliance. Apply today to start your journey with a trusted industry leader.
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