Apply for Regulatory Associate Syneos Health job 2026. Check eligibility, salary, selection process, and online application details for pharma candidates.
Introduction
If you are looking to build a career in regulatory affairs within the pharmaceutical industry, this opportunity at Syneos Health could be a great starting point. The company is hiring for the role of Regulatory Associate with exposure to EU markets and CMC Module 3. This role is ideal for freshers or candidates with up to 2 years of experience who want to grow in global regulatory submissions and drug development processes.
Job Overview
| Particulars | Details |
|---|---|
| Job Title | Regulatory Associate (EU Market, CMC Module 3) |
| Company Name | Syneos Health |
| Location | Remote / Gurugram (Hybrid Option) |
| Employment Type | Full-Time |
| Department | Regulatory Affairs |
| Experience Required | 6 Months – 2 Years |
| Education | B.Pharm / M.Pharm / Life Sciences |
| Salary | As per company norms |
Company Overview
Syneos Health is a globally recognized organization that supports pharmaceutical, biotech, and healthcare companies across drug development and commercialization. With a strong presence in clinical research and regulatory services, the company has contributed to a majority of recent FDA and EMA-approved drugs. It offers a dynamic environment where professionals can work on global regulatory projects and gain valuable industry exposure.
Job Location & Employment Type
- Work Mode: Remote (Pre-approved) or Hybrid (Gurugram)
- Job Type: Full-Time
- Work Environment: Collaborative and project-driven with global teams
Open Positions / Department Details
- Department: Regulatory Affairs
- Domain: EU Market Regulatory Submissions
- Focus Area: CMC Module 3 (Chemistry, Manufacturing, and Controls)
This role mainly supports regulatory documentation, submissions, and lifecycle management activities for pharmaceutical products.
Key Roles & Responsibilities
- Assist in preparing regulatory documents such as IND, NDA, MAA, and DMF submissions
- Support lifecycle management activities including variations, renewals, and authorizations
- Conduct regulatory research and gather data for submissions
- Perform quality checks on documents to ensure compliance with guidelines
- Help in preparing clinical development plans and gap analysis reports
- Coordinate with internal teams to collect required information
- Compile and analyze regulatory data for reporting purposes
- Support orphan drug designation applications and regulatory filings
- Maintain proper documentation and records for regulatory processes
Eligibility Criteria
Education
- Bachelor’s or Master’s degree in Pharmacy or Life Sciences (B.Pharm / M.Pharm / M.Sc preferred)
Experience
- 6 months to 2 years of experience in regulatory affairs
- Internship experience in regulatory domain is highly preferred
- Exposure to CMC (small molecule) is an advantage
Skills Required
- Strong understanding of regulatory guidelines (EU, GCC, APAC preferred)
- Good communication and interpersonal skills
- Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
- Strong analytical and problem-solving ability
- Attention to detail and accuracy
- Ability to work independently as well as in teams
- Time management and multitasking skills
Salary & Benefits
- Salary: As per company norms
- Career development and growth opportunities
- Exposure to global regulatory markets
- Training and skill enhancement programs
- Inclusive and supportive work culture
- Performance recognition and rewards
Selection Process
The selection process typically includes:
- Application screening
- HR discussion
- Technical interview
- Final selection
How to Apply
Interested candidates can apply through the official company career portal:
- Visit the official website of Syneos Health
- Search for “Regulatory Associate (EU mkt, CMC module 3)”
- Submit your updated resume online
Important Dates
- Last Date: Not specified
Why Apply for This Job?
This role is a great opportunity for early-career professionals aiming to enter global regulatory affairs. You will gain hands-on experience in EU submissions and CMC documentation, which are highly valuable skills in the pharma industry. Working with a reputed company like Syneos Health also enhances your professional credibility and opens doors for future career growth in clinical research and regulatory domains.
FAQs
1. What is the experience required for this role?
Candidates with 6 months to 2 years of experience can apply. Freshers with internships are also preferred.
2. Is this job remote or office-based?
The job offers both remote and hybrid working options (Gurugram).
3. What qualifications are required?
B.Pharm, M.Pharm, or Life Sciences graduates are eligible.
4. What is the salary for this position?
Salary is not disclosed and will be as per company norms.
5. How can I apply for this job?
You can apply online through the official Syneos Health careers page.
Conclusion
The Regulatory Associate role at Syneos Health is an excellent opportunity for candidates looking to establish a career in regulatory affairs with international exposure. With flexible working options, strong learning opportunities, and a global work environment, this job can be a significant step forward in your pharma career. Interested candidates should apply as soon as possible to avoid missing out.
Disclaimer
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