Regulatory Consultant (CMC/ EU Market Exp)
Updated: August 20, 2025
Location: IND – Remote
Job ID: 25101141
💰 Estimated Salary: ₹18 – 28 LPA (based on Indian market benchmarks for senior regulatory affairs consultants with 5+ years’ CMC/EU market experience)
Description
Syneos Health® is a leading, fully integrated biopharmaceutical solutions provider focused on accelerating customer success. With a global footprint of 29,000 employees across 110 countries, we support clients in bringing therapies to market faster, through our integrated clinical, medical affairs, and commercial services.
We are seeking an experienced Regulatory Consultant (CMC/ EU Market) to provide regulatory and technical support for CMC-related post-approval lifecycle management, submissions, and client engagement. This role is remote, offering flexibility while working on high-impact global projects.
Key Responsibilities
Regulatory Submissions & CMC Support
Author and review Module 3 (CMC sections) for post-approval variations, renewals, annual reports, legal entity name changes, and lifecycle maintenance.
Assess regulatory impact of change controls and develop submission strategies.
Conduct gap analyses and support product development plans per EU and global regulatory requirements.
Prepare administrative and technical components of IND, NDA, MAA, PMA, CTD, and other submissions.
Contribute to briefing packages for regulatory authority meetings/scientific advice sessions.
Project & Client Management
Manage daily regulatory activities for assigned projects per timelines, scope, and budgets.
Act as regulatory SME in multidisciplinary teams, supporting lifecycle management and new development projects.
Provide solutions and troubleshooting for project-related challenges.
Support business development through proposal inputs, cost estimates, and client meetings.
Quality & Compliance
Ensure compliance with global regulatory standards (EU, GCC, MEA).
Participate in audits, inspections, and internal initiatives.
Contribute to the creation/maintenance of SOPs and process documents.
Maintain individual training compliance and certifications.
Leadership & Knowledge Sharing
Mentor team members and provide oversight for project execution.
Develop training materials and share best practices internally and externally.
Drive process improvements in regulatory operations.
Qualifications
Education: MS, M.Pharm, or PhD in life sciences or equivalent.
Experience: 5+ years in Regulatory Affairs, including 4+ years in CMC with EU market focus.
Strong knowledge of EU regulatory frameworks (mandatory); experience in GCC & MEA markets preferred.
Proven expertise in post-approval CMC variations, renewals, IND, NDA, MAA, CTD submissions (electronic).
Hands-on experience with RIMS tools (Veeva RIMS, TrackWise preferred).
Excellent English communication (written & spoken) with client-facing experience.
Strong initiative, adaptability, analytical thinking, and multitasking abilities.
Advanced MS Office skills; experience with regulatory publishing systems a plus.
Why Join Syneos Health?
Global exposure to EU, GCC, and MEA regulatory frameworks.
Remote work flexibility with international collaboration.
Career growth through training, mentoring, and cross-functional projects.
A diverse, inclusive Total Self culture where authenticity is valued.
Summary
The Regulatory Consultant (CMC/EU Market) role is ideal for experienced regulatory professionals with proven post-approval lifecycle management and EU submission expertise. Responsibilities span CMC authoring, change control assessments, client engagement, regulatory submissions, and cross-functional project leadership. With exposure to EU, GCC, and MEA regulatory markets, this position offers both technical depth and strategic client interaction in a global setting.
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