Syneos Health Hiring for Associate Regulatory Affairs
Position: Associate – Regulatory Affairs (Module 1 & Regulatory Submission)
Company: Syneos Health
Location: Remote (India) / Hybrid – Gurugram
Qualification: Master’s in Pharmaceutical Sciences (M.Pharm or equivalent)
Experience: Around 2 Years
Employment Type: Full-Time
Job Category: Regulatory Affairs
Status: Verified Job
Application Mode: Online
About Syneos Health
Syneos Health® is a global leader in biopharmaceutical solutions, combining clinical development, regulatory affairs, and commercial expertise to accelerate drug innovation and improve patient outcomes.
Operating across 110 countries with 29,000+ employees, Syneos Health partners with top pharmaceutical and biotechnology companies to bring new therapies to market faster.
Over the past five years, the organization has contributed to the development of:
✅ 94% of all novel FDA-approved drugs
✅ 95% of EMA-authorized products
✅ 200+ studies across 73,000 sites and 675,000+ patients globally.
At Syneos Health, Work Here Matters Everywhere™ — because every role contributes to transforming patient lives worldwide. Syneos Health Hiring for Associate Regulatory Affairs
Position Overview
Syneos Health is inviting applications for the role of Associate – Regulatory Affairs (Module 1 & Regulatory Submission).
This role is ideal for individuals who are detail-oriented and have a strong understanding of regulatory documentation, global submission processes, and pharmaceutical guidelines. You will support regulatory submissions such as INDs, NDAs, MAAs, DMFs, and lifecycle maintenance activities while ensuring compliance with health authority requirements. Syneos Health Hiring for Associate Regulatory Affairs
The position offers flexibility with both remote and hybrid working options from Gurugram, India.
Key Responsibilities
As an Associate in Regulatory Affairs, you will assist the regulatory team in preparing, managing, and maintaining global submission documentation. Syneos Health Hiring for Associate Regulatory Affairs
Essential Duties:
- Prepare and review Module 1 documents and collect country-specific administrative forms.
- Assist in preparing regulatory submission components including INDs, NDAs/MAAs, DMFs, variations, renewals, and MATs.
- Draft responses to Health Authority queries and ensure tracking of commitments.
- Maintain and update regulatory trackers, submission timelines, and project status reports.
- Ensure accurate archiving of submission documents in compliance with internal SOPs.
- Conduct regulatory research to identify precedents and support preparation of orphan drug designation requests.
- Gather information and prepare detailed reports or correspondence as required.
- Provide support to internal teams and clients with general regulatory information and documentation queries.
- Syneos Health Hiring for Associate Regulatory Affairs
Required Qualifications
Education:
- Master’s degree in Pharmaceutical Sciences (M.Pharm or equivalent) is required.
Experience:
- Around 2 years of experience in a Regulatory Affairs, Quality Assurance, or Document Management support role in the pharmaceutical or CRO sector.
Skills & Competencies:
- Excellent understanding of regulatory submission processes and global documentation requirements.
- Advanced proficiency in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
- Strong communication and interpersonal skills.
- Good project management and organizational abilities.
- Ability to work independently and meet strict submission timelines.
Why Join Syneos Health
At Syneos Health, you’ll experience a culture that prioritizes growth, inclusion, and collaboration.
Key Benefits:
- Continuous learning and career development opportunities.
- A supportive and engaged management team.
- Recognition and rewards programs for high performance.
- A Total Self Culture that encourages authenticity and inclusion.
- Exposure to global pharmaceutical regulations and industry best practices.
Syneos Health is building the company everyone wants to work for — and that clients love to work with. When people from diverse backgrounds, cultures, and perspectives collaborate, innovation thrives. Syneos Health Hiring for Associate Regulatory Affairs
Additional Information
- This job description outlines the general responsibilities of the role. The company may assign other tasks as necessary.
- Equivalent experience, education, or skills may be considered.
- Syneos Health is committed to diversity, inclusion, and equal employment opportunity.
- The company complies with all applicable laws, including the Americans with Disabilities Act (ADA), and provides reasonable accommodations when required.
- Syneos Health Hiring for Associate Regulatory Affairs
How to Apply
Interested candidates can apply directly through the official Syneos Health careers portal using the link below: Syneos Health Hiring for Associate Regulatory Affairs
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
