Syneos Health is hiring for a Regulatory Consultant (CMC-EU, GCC & AU) position on a full-time, remote basis in India. The role focuses on CMC regulatory writing, CTD Module 3 authoring, post-approval variations, regulatory submissions, and lifecycle management for small-molecule products across global markets.

Job Details

Position

Regulatory Consultant (CMC-EU, GCC & AU)

The position requires hands-on experience in CMC authoring, including independent preparation of CTD Module 3 sections and regulatory content based on technical CMC documentation.

Job Responsibilities

• Conduct research on existing product data against global or regional regulatory requirements for gap analyses, product development plans, and regulatory submissions.
• Prepare or contribute to administrative and technical components of regulatory submissions, including INDs, pre-approval submission packages, product registration applications, and post-approval maintenance.
• Prepare briefing packages for regulatory agency meetings or scientific advice and support agency interactions.
• Manage day-to-day regulatory activities according to agreed timelines, scope, budgets, and strategies.
• Provide regulatory support on multidisciplinary project teams throughout the product lifecycle.
• Act as a subject matter expert and support troubleshooting of project-related regulatory issues.
• Prepare estimates for regulatory services for single or multiple service proposals.
• Support client meetings concerning proposals, project status, and business development activities.
• Ensure compliance with applicable global regulatory requirements and company policies and processes.
• Prepare regulatory training materials and share best practices internally and externally.
• Support internal or external project audits from a regulatory perspective.
• Participate in internal cross-functional regulatory initiatives.
• Contribute to SOPs and other process-related documentation.
• Provide oversight support to team members in executing project responsibilities.
• Identify situations requiring additional line support or guidance.
• Maintain individual training records and complete required training.

Eligibility / Qualifications

Candidates should have:

• Experience independently authoring CTD Module 3 (M3) sections.
• Hands-on CMC authoring exposure.
• Experience with post-approval variations/supplements.
• Experience with CMC writing and lifecycle management for small molecules.
• Experience working across regulatory markets such as EU, USFDA, Australia, GCC, or ROW; experience in all regions is not required.
• Ability to interpret technical data and write regulatory content from raw CMC documents.
• Ability to own CTD sections.
• Experience defending regulatory content in authority queries.
• Knowledge of CTD section numbers and regulatory expectations.
• Ability to interact cross-functionally with analytical, formulation, and manufacturing teams.

Candidates whose experience is limited to document compilation or review are not aligned with the mandatory skill requirements.

Required Skills

Key skills for the Regulatory Consultant role include:

• CMC regulatory writing
• CTD Module 3 authoring
• Small-molecule CMC lifecycle management
• Post-approval variations and supplements
• Regulatory submissions
• Technical data interpretation
• Regulatory authority query responses
• Global regulatory requirements
• Cross-functional collaboration
• Analytical, formulation, and manufacturing coordination
• Regulatory gap analysis
• Product development planning
• Regulatory agency interactions

Application Details

Interested candidates can apply for the Regulatory Consultant (CMC-EU, GCC & AU) position through the Syneos Health careers portal.

Job Requisition ID: 25110577
Location: IND-Remote
Work Type: Remote (Pre-Approved)
Employment Type: Full Time

Application Link