Syneos Health Hiring Regulatory Associate : RA Jobs 2026
Syneos Health,Contract Research Organization (CRO) is hiring a Regulatory Affairs Associate for its Clinical Solutions team, focused on the EU market (CMC – Module 3). This remote opportunity in India is ideal for candidates with 0.5–2 years of experience in CMC regulatory activities, especially involving small‑molecule products.
The role involves supporting EU regulatory submissions, including IND, NDA, and MAA filings, along with post‑approval lifecycle management activities. Candidates will gain hands‑on exposure to Chemistry, Manufacturing & Controls (CMC) documentation, working closely with global regulatory and technical teams.
This is a valuable early‑career opportunity for professionals looking to build strong expertise in EU regulatory affairs, CMC submissions, and pharmaceutical product development within a globally regulated environment..
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🏢 About the Company
Syneos Health is a global organization that delivers integrated solutions across clinical development, regulatory services, and commercialization for healthcare and pharmaceutical companies. The organization operates in regulated environments and follows structured quality and compliance systems. Employees gain valuable exposure to regulatory workflows, documentation standards, and cross‑functional collaboration, making it a strong workplace for professionals interested in long‑term growth in life sciences.
📊 Role Overview
- Position: Regulatory Associate (EU mkt, CMC module 3)
- Department: Regulatory affairs
- Location: Remote/Gurugram(Hybrid),India
- Experience: 0.5 to 2 years
- Qualification: B.Pharm, M.pharm
- Job Type: Full-Time
- Last Date of application: Not provided
📋 Key Responsibilities – Regulatory Associate (EU mkt, CMC module 3)
- Help prepare product development documents, such as gap analysis reports and clinical development plans.
- Support the preparation of regulatory submission documents for various filings, including:
- INDs (Investigational New Drugs)
- NDAs / MAAs (New Drug / Marketing Authorisation Applications)
- DMFs (Drug Master Files)
- Variations, renewals, and licence transfers (MATs)
- Other post‑approval and lifecycle management activities
All work is done following current regulatory guidelines and regulations.
- Carry out regulatory research to understand past approvals and regulatory precedents, including support for orphan drug designation requests.
- Perform quality checks on regulatory documents to ensure accuracy, completeness, and compliance.
- Assist with the submission of additional regulatory documents and help with ad‑hoc regulatory research when required.
- Provide general regulatory information to clients, internal teams, or stakeholders as needed.
- Collect, organize, analyze, and report regulatory‑related data and information.
- Search files, records, and databases, and contact relevant teams or individuals to gather required information.
- Prepare basic reports and routine regulatory correspondence based on the collected information.
🎓 Qualification & Skills Required
- You should have 6 months to 2 years of experience in Regulatory Affairs or a related role.
- Internship experience in regulatory or pharmaceutical fields is preferred.
- Basic knowledge or hands‑on experience with CMC activities (Module 3) for small‑molecule products is required.
- Experience with regulatory submissions for EU markets is preferred.
- Exposure to GCC or APAC markets is an added advantage.
- You should have good communication skills and be comfortable interacting with people from different teams.
- Strong working knowledge of Microsoft Office tools such as Word, Excel, and PowerPoint is required.
- Good time management and project coordination skills are preferred, as you may handle multiple tasks at the same time.
- Must have strong attention to detail and basic analytical thinking skills.
- Ability to work both independently and as part of a team, and follow detailed instructions carefully.
- Comfortable working on multiple projects at the same time, where instructions may vary project to project.
- Should be fluent in English (reading, writing, and speaking).
⭐ Role Insight
The Regulatory Associate role plays a crucial role in ensuring that pharmaceutical products meet regulatory requirements before and after they reach the market. Professionals in this position contribute behind the scenes by managing documentation and supporting submissions that are essential for product approvals, variations, and compliance maintenance. This role provides a strong foundation for a long‑term career in regulatory affairs
🎯 Ideal Candidates
This opportunity is suitable for:
- Fresh graduates interested in regulatory affairs
- Professionals seeking entry into the RA domain
- Candidates with documentation or compliance background
- Individuals aiming to build a structured pharma career
💡 Expert Tips
- Learn basic regulatory terminology and workflows
- Understand the importance of documentation accuracy
- Highlight compliance‑related skills in your resume
- Prepare for interview questions related to regulatory processes
🔗 Application Link
Interested candidates should apply only through the official company career website using the link provided below.
Important Disclaimer
This job post is shared for informational purposes only, based on publicly available job details. Candidates are advised to verify eligibility, job responsibilities, and application procedures from the official website before applying.
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❓ Frequently Asked Questions (FAQs)
1. Who can apply for this role?
Candidates with 6 months to 2 years of experience in Regulatory Affairs or CMC work can apply. Internship experience in regulatory or CMC is also acceptable. Freshers with relevant exposure may be considered.
2. What educational background is required?
A degree in Pharmacy or Life Sciences such as B.Pharm or M.Pharm is required.
3. Is this role suitable for early‑career professionals?
This role is ideal for early‑career candidates who want to build strong experience in EU regulatory submissions and CMC Module 3.
4. What kind of work will I do in this role?
You will help prepare CMC regulatory documents, support EU submissions (IND/NDA/MAA), perform quality checks, and assist with lifecycle management activities like variations and renewals.
5. Do I need experience with EU regulatory markets?
Experience with the EU market is preferred. Exposure to GCC or APAC markets is an added advantage but not mandatory.
