Syneos Health has announced an opening for the position of Regulatory Consultant (CMC-EU, GCC & AU) for candidates based in India. The position is full-time and offered as a Remote (Pre-Approved) role.
This opportunity is focused on CMC regulatory writing, CTD Module 3 authoring, post-approval variations, lifecycle management and global regulatory submissions for pharmaceutical products, particularly small molecules.
Job Details
| Particulars | Details |
|---|---|
| Company | Syneos Health |
| Position | Regulatory Consultant (CMC-EU, GCC & AU) |
| Location | India – Remote |
| Work Model | Remote (Pre-Approved) |
| Employment Type | Full Time |
| Job ID | 25110577 |
| Specialization | Regulatory Affairs / CMC |
| Focus Areas | CTD Module 3, CMC Writing, Lifecycle Management |
Job Overview
The Regulatory Consultant will be responsible for providing regulatory support for pharmaceutical products throughout their development and commercial lifecycle.
The role particularly requires hands-on experience in CMC authoring, including independent preparation of CTD Module 3 (M3) sections. Candidates whose experience is limited to document compilation or review may not meet the stated requirements.
The position involves working with analytical, formulation and manufacturing teams and supporting regulatory submissions across multiple regions, including EU, USFDA, Australia, GCC and other markets.
Mandatory Skills & Experience
Candidates should have experience in:
- CMC regulatory writing.
- Independently authoring CTD Module 3 sections.
- Preparing content directly from raw CMC technical documents.
- Interpreting technical CMC data.
- Owning assigned CTD sections.
- Understanding CTD section numbers and regulatory expectations.
- Post-approval variations and supplements.
- CMC writing and lifecycle management for small-molecule products.
- Working with analytical, formulation and manufacturing teams.
- Supporting regulatory activities across markets such as EU, USFDA, Australia, GCC and ROW.
Candidates should also be able to support responses to regulatory authority questions and defend the technical content included in submissions.
Key Responsibilities
- Research existing product information against global and regional regulatory requirements.
- Prepare gap analyses, product development plans and regulatory submission documents.
- Prepare administrative and technical components of regulatory agency submissions.
- Support IND, pre-approval, product registration and post-approval submissions.
- Prepare briefing packages for regulatory agency meetings and scientific advice.
- Support interactions with regulatory authorities.
- Manage day-to-day regulatory activities according to project timelines, scope, budgets and strategies.
- Participate as a regulatory expert on multidisciplinary project teams.
- Work with clinical and technical experts during product development and lifecycle management.
- Act as a subject matter expert for regulatory troubleshooting.
- Identify project-related problems and help develop appropriate solutions.
- Prepare estimates for regulatory services for proposals.
- Support client meetings related to proposals and ongoing projects.
- Support general business development activities.
- Ensure compliance with applicable global regulatory requirements and company policies.
- Prepare regulatory training materials and share best practices.
- Participate in internal and external project audits.
- Support internal cross-functional regulatory initiatives.
- Contribute to the development and maintenance of SOPs and process documentation.
- Provide oversight and guidance to team members when required.
- Identify situations where additional line support or guidance is required.
- Maintain required individual training records and complete designated training.
Regulatory Areas
The role may involve regulatory activities across multiple regions, including:
- European Union (EU)
- USFDA
- Australia (AU)
- GCC
- Rest of World (ROW)
Experience in all regions is not necessarily required, as the job description specifically mentions experience across these markets rather than requiring every region.
Candidate Profile
The ideal candidate should have strong hands-on CMC regulatory writing experience and be comfortable taking ownership of CTD sections.
Particularly relevant experience includes:
- CTD Module 3 authoring
- CMC documentation
- Regulatory submissions
- Post-approval variations
- Regulatory lifecycle management
- Small-molecule products
- Regulatory authority responses
- Cross-functional collaboration
- Global regulatory requirements
Important Requirement
Candidates who have only compiled or reviewed CMC documents may not fit this position.
The role specifically requires candidates who have experience independently authoring CTD Module 3 sections, interpreting technical data and developing regulatory content from source CMC documents.
Work Location
India – Remote
Work Model: Remote (Pre-Approved)
How to Apply
Interested and eligible candidates can apply online through the official Syneos Health careers portal.
Company: Syneos Health
Position: Regulatory Consultant (CMC-EU, GCC & AU)
Location: India – Remote
Job ID: 25110577
Employment Type: Full Time
Apply Online
Note: Candidates should review the official job posting carefully and verify the current status, eligibility requirements and application details before applying.