Syneos Health Hiring Regulatory Consultant | Remote & Hybrid in Gurugram
- Syneos Health Hiring Regulatory Consultant (EU Market – Module 3 CMC) in Gurgaon | Hybrid Opportunity
- Company Overview
- Job Role & Responsibilities
- CMC Module 3 Authoring & Lifecycle Management
- Regulatory Submissions & Documentation
- Project & Client Management
- Compliance & Quality Support
- Team Leadership & Knowledge Sharing
- Eligibility / Qualifications
- Educational Qualifications
- Experience Requirements
- Technical Competencies
- Core Skills
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- Summary Table
Syneos Health Hiring Regulatory Consultant (EU Market – Module 3 CMC) in Gurgaon | Hybrid Opportunity
Syneos Health is hiring for the position of Regulatory Consultant (EU Market – Module 3 CMC) in Gurgaon, Haryana (Hybrid work model). This is a full-time opportunity for experienced regulatory affairs professionals with 4–5 years of experience in CMC documentation, post-approval variations, and lifecycle management activities. The role specifically requires strong exposure to EU and GCC markets and hands-on expertise in Module 3 (Quality/CMC) authoring and regulatory submissions. This is a single consultant-level opening within the global regulatory consulting function.
This opportunity is ideal for M.Pharm professionals seeking advanced regulatory affairs careers in global submissions, electronic CTD preparation, EU regulatory strategy, and pharmaceutical lifecycle management within a leading global CRO.
Company Overview
Syneos Health is a globally recognized, fully integrated biopharmaceutical solutions organization operating across clinical development, regulatory affairs, medical affairs, and commercialization. With more than 29,000 employees across 110 countries, the company partners with pharmaceutical, biotechnology, and medical device organizations to accelerate the development and delivery of therapies worldwide.
Syneos Health has supported a significant proportion of FDA-approved drugs and EMA-authorized products in recent years. Its regulatory consulting teams work on complex global submissions, product registrations, lifecycle strategies, and agency interactions across multiple therapeutic areas.
The organization promotes a collaborative and performance-driven culture, offering structured career progression, therapeutic training, and exposure to multinational regulatory environments. Working here means contributing to the global development of life-changing medicines while operating in a compliance-focused, innovation-driven ecosystem.
Job Role & Responsibilities
The Regulatory Consultant will provide regulatory and technical support for assigned product development programs, with a strong focus on CMC Module 3 documentation and EU market submissions. The role requires independent management of regulatory activities for both non-complex and complex submissions.
CMC Module 3 Authoring & Lifecycle Management
- Author and review CMC (Chemistry, Manufacturing and Controls) sections of regulatory submissions
- Prepare documentation for post-approval variations and lifecycle management activities
- Support EU and GCC market regulatory requirements for quality modules
- Ensure technical accuracy, consistency, and compliance with regional guidelines
Regulatory Submissions & Documentation
- Contribute to preparation of regulatory submission packages including IND, NDA, MAA, CTD, and electronic submissions
- Conduct gap analysis based on existing product data and regional regulatory requirements
- Prepare administrative and technical components of submission dossiers
- Support preparation of briefing packages for scientific advice and regulatory meetings
Project & Client Management
- Manage day-to-day regulatory activities in line with agreed timelines and scope of work
- Participate in multidisciplinary project teams involving clinical, quality, and manufacturing experts
- Act as subject matter expert for CMC-related troubleshooting and regulatory strategy discussions
- Provide input for regulatory service proposals and support business development discussions
Compliance & Quality Support
- Ensure alignment with global regulatory requirements and internal SOPs
- Participate in internal and external audits
- Contribute to development and maintenance of regulatory SOPs and documentation standards
- Support cross-functional initiatives related to regulatory excellence and continuous improvement
Team Leadership & Knowledge Sharing
- Provide guidance and oversight to team members as required
- Prepare training materials and share regulatory best practices internally and externally
- Maintain individual training records and ensure completion of mandatory compliance training
This position requires strong analytical ability, attention to detail, and the capability to handle multiple concurrent regulatory projects with varying requirements.
Eligibility / Qualifications
This role is intended for experienced regulatory affairs professionals with strong CMC expertise and EU market exposure.
Educational Qualifications
M.Pharm, B.Pharm, Master’s in Pharmaceutical Sciences, PhD in Life Sciences or related scientific discipline
Experience Requirements
- Minimum 4–5 years of experience in Regulatory Affairs
- Proven experience in Module 3 (CMC) documentation and authoring
- Experience in EU and GCC market submissions is mandatory
- Exposure to electronic CTD submissions and lifecycle management activities
Technical Competencies
- Knowledge of global regulatory frameworks including EMA and FDA requirements
- Familiarity with IND, NDA, MAA, CTD submission structures
- Strong understanding of pharmaceutical manufacturing and quality documentation
- Advanced proficiency in Microsoft Office applications
- Excellent written and verbal English communication skills
Core Skills
- Strong analytical and problem-solving ability
- Customer-focused mindset with ability to work independently and in teams
- High attention to detail and quality orientation
- Ability to manage multiple regulatory projects simultaneously
Location & Salary
Job Location: Gurgaon, Haryana, India
Work Model: Hybrid
Employment Type: Full-time
Application Process
Interested candidates can apply through Syneos Health’s official career portal using the link below:
Applications are reviewed on an ongoing basis. Early application is recommended.
Frequently Asked Questions (FAQs)
Who can apply for the Regulatory Consultant (EU Module 3) role?
Candidates with 4–5 years of regulatory affairs experience and strong CMC Module 3 authoring exposure can apply.
Is EU market experience mandatory?
Yes. Prior experience in EU and GCC regulatory submissions is required.
Is this role focused on CMC documentation?
Yes. The primary responsibility includes authoring and reviewing Module 3 (CMC) documentation.
Is this a permanent position?
Yes. This is a full-time role under Syneos Health.
Does this role involve global submissions?
Yes. The consultant will support EU and other international regulatory submissions.
Summary Table
| Company | Syneos Health |
|---|---|
| Vacancies | Regulatory Consultant (EU Market – Module 3 CMC) |
| Required Education | M.Pharm, B.Pharm, Pharmaceutical Sciences, PhD |
| Experience | 4–5 Years |
To apply for this job please visit syneoshealth.wd12.myworkdayjobs.com.
