Regulatory Consultant – CMC (EU/Japan/China) – Remote (India)
Job Summary:
Syneos Health is seeking an experienced Regulatory Consultant (CMC) to support global submissions for the EU, Japan, and China markets. This fully remote, India-based role offers an opportunity to lead both non-complex and complex regulatory submissions. If you have a strong background in regulatory strategy, CMC dossier preparation, and cross-functional collaboration, this is your chance to impact global drug development from anywhere in India.
Key Responsibilities:
Prepare regulatory documents for INDs, pre-approval submissions, product registrations, and post-approval changes.
Conduct regulatory gap analyses and contribute to product development plans.
Participate in and manage client meetings, agency interactions, and internal project reviews.
Serve as a subject matter expert in regulatory requirements across global markets.
Coordinate regulatory activities and ensure compliance with global standards.
Prepare briefing documents and support scientific advice processes.
Create training material, support audits, and contribute to SOP development.
Provide oversight and mentorship to junior regulatory staff.
Support business development efforts including regulatory cost estimation.
Required Skills & Qualifications:
Experience in CMC regulatory submissions across EU, Japan, and China.
Strong understanding of global regulatory frameworks and agency expectations.
Excellent organizational and communication skills.
Experience preparing documents such as INDs, MAAs, DMFs, and scientific advice packages.
Familiarity with regulatory software and submission tools.
Proven ability to work independently and manage multiple complex projects.
Experience in client-facing roles is preferred.
Bachelor's or Master’s in Pharmacy, Life Sciences, or a related discipline.
Hands-on experience in drug product submissions is essential.
Perks & Benefits:
Fully remote work flexibility from anywhere in India
Opportunity to work with global regulatory teams
Access to world-class learning and development programs
Performance-driven career progression
Inclusive and diverse workplace culture
Exposure to high-impact clinical projects and global drug approvals
Competitive compensation (not specified in job post)
Company Overview:
Syneos Health is a globally recognized leader in biopharmaceutical solutions. With operations in over 110 countries and partnerships supporting 94% of novel FDA approvals, the company delivers full-service clinical, regulatory, and commercial services to help bring new therapies to market faster.
Work Mode:
Remote – India
Call to Action:
Ready to drive regulatory innovation on a global scale? Apply now to join Syneos Health as a Regulatory Consultant (CMC) and contribute to impactful drug development across the EU, Japan, and China. Your regulatory expertise can help transform healthcare worldwide.
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