Regulatory Consultant (CMC – EU/Japan/China) – Syneos Health | Gurgaon, India
Job Summary
Syneos Health is hiring a Regulatory Consultant (CMC – EU/Japan/China) to manage global regulatory submissions and product registration strategies. This role focuses on drug product regulatory submissions, INDs, pre-approval packages, and post-approval maintenance for international markets. The position requires expertise in regulatory documentation, compliance with global regulatory standards, and cross-functional project management to support pharmaceutical product life cycles.
Key Responsibilities
Lead regulatory submissions for EU, Japan, and China, including INDs and pre/post-approval packages.
Prepare and review gap analyses, product development plans, and registration applications.
Develop briefing packages for regulatory agency meetings and provide technical support during interactions.
Oversee day-to-day regulatory activities while ensuring compliance with project timelines and budgets.
Participate as regulatory support in cross-functional teams to develop strategies across the product lifecycle.
Provide troubleshooting and subject matter expertise for project-related challenges.
Prepare estimates for regulatory service proposals and support client meetings.
Ensure compliance with global regulatory requirements and internal SOPs.
Prepare training materials and share regulatory best practices.
Participate in internal and external project audits.
Support in the creation and maintenance of SOPs and regulatory process documentation.
Mentor and guide team members in execution of regulatory tasks.
Required Skills & Qualifications
Strong hands-on experience in drug product CMC regulatory affairs.
Proven expertise with EU, Japan, and China regulatory frameworks.
Experience in IND submissions, product registrations, and post-approval maintenance.
Excellent knowledge of global regulatory standards and compliance processes.
Strong problem-solving, documentation, and team collaboration skills.
Ability to work in a fast-paced and deadline-driven environment.
Perks & Benefits
Competitive compensation package (salary not disclosed).
Career advancement and professional development programs.
Technical and therapeutic area training opportunities.
Comprehensive health benefits and work-life balance support.
Recognition programs and a collaborative global work culture.
Company Description
Syneos Health is a leading biopharmaceutical solutions company offering integrated clinical development, regulatory affairs, and commercial services. With over 29,000 employees across 110 countries, the company has supported 94% of all FDA-approved novel drugs in the last five years.
Work Mode: On-site – Gurgaon, India
Call to Action
If you have strong experience in CMC regulatory affairs and global submissions, this is your chance to work on impactful regulatory strategies with a global leader. Apply now to join Syneos Health.
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