Regulatory Consultant CMC – EU/Japan/China | Syneos Health

Regulatory Consultant CMC – EU/Japan/China | Syneos Health India

Syneos Health hiring Regulatory Consultant (CMC) in Gurugram. Life sciences grads with regulatory experience in EU, Japan, or China submissions apply now!

Regulatory Consultant (CMC – EU/Japan/China) Job Opening at Syneos Health – Gurugram, Hybrid Role

Drive Global Regulatory Submissions in a High-Impact Biopharma Role

Looking to accelerate your career in regulatory affairs and CMC submissions? Syneos Health®, a leading global biopharmaceutical solutions provider, is seeking experienced professionals for the position of Regulatory Consultant – CMC (EU/Japan/China). This hybrid role is based in Gurugram, India.

If you’re a graduate in life sciences or pharmacy with a strong foundation in drug product regulatory strategies, this opportunity places you at the heart of international regulatory operations in a collaborative, patient-centered environment.

Key Responsibilities

What You’ll Be Doing:

• Conduct regulatory intelligence and data gap analyses for global or regional submissions.
• Prepare or contribute to INDs, product registrations, pre-approval packages, and post-approval documentation.
• Support regulatory agency meetings and the preparation of briefing documents.
• Manage end-to-end delivery of regulatory activities as per timelines and contract scope.
• Act as SME for assigned projects, providing troubleshooting and regulatory guidance.
• Collaborate on cross-functional teams to support clinical development.
• Participate in client meetings, proposals, and project planning sessions.
• Ensure compliance with global regulatory guidelines and internal SOPs.
• Train team members and share regulatory best practices.
• Provide audit support and contribute to SOP/process development.

Candidate Profile & Qualifications

Educational & Technical Requirements:

• Educational Background: Bachelor’s or Master’s in Life Sciences, Pharmacy, Biotechnology or related field.
• Experience: 3–7 years in CMC regulatory affairs, including global submissions to authorities in EU, Japan, or China.
• Strong understanding of drug development, dossier compilation, and international regulatory frameworks.
• Excellent communication and collaboration skills in cross-functional environments.

Location

📍 Gurugram, India – Hybrid (Office + Remote)

Why Choose Syneos Health?

• Collaborate with a company that supported 94% of FDA novel drug approvals in the last 5 years.
• Work alongside 29,000+ professionals across 110 countries.
• Thrive in a Total Self culture where inclusion, personal well-being, and professional growth are prioritized.
• Competitive salary packages with global benefits including:
  • Health and life insurance
  • Retirement planning
  • Leave entitlements
  • Employee Assistance Program (EAP)
  • Flexible benefits: gym discounts, travel vouchers, health assessments, etc.

Apply Online

Want to lead regulatory strategy across global markets? Apply Now and join Syneos Health’s mission to bring life-changing therapies to patients faster.

Career Opportunities Snapshot