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Syneos Health®, a global leader in biopharmaceutical solutions, is hiring a Regulatory Associate (EU Market) for a homebased role in India. Join our mission to accelerate therapies that transform lives. Apply now!
Why Syneos Health?
At Syneos Health, we’re passionate about shortening the distance from lab to life. With over 29,000 employees across 110 countries, our work supports 94% of FDA-approved drugs and 95% of EMA-authorized products. We foster a Total Self culture, embracing diversity and inclusion.
About the Role
As a Regulatory Associate (EU Market), you’ll support global clinical trials remotely from India. This role, updated on July 18, 2025, offers a chance to grow in regulatory affairs while contributing to innovative healthcare solutions.
Key Responsibilities
Your role will involve critical regulatory tasks to ensure compliance and trial success:
- Document Preparation: Assist in creating product development documents, including gap analyses and clinical development plans.
- Regulatory Submissions: Prepare components for INDs, NDAs/MAAs, DMFs, variations, renewals, and marketing authorization transfers.
- Research & Analysis: Conduct regulatory research to support orphan drug designation requests and identify precedents.
- Quality Assurance: Perform quality checks on regulatory documents to ensure accuracy and compliance.
- Data Compilation: Gather, analyze, and report information to support detailed reports and correspondence.
- Cross-Functional Collaboration: Interact with multiple departments to streamline processes and meet project goals.
Qualifications and Requirements
| Criteria | Details |
|---|---|
| Education | Master’s in Pharmacy (preferred) or Science/Healthcare field |
| Experience | Minimum 1 year in Global Regulatory Affairs, CMC experience preferred |
| Skills | Strong analytical, communication, and Microsoft Office skills |
| Language | Fluent in English (speaking, writing, reading) |
| Work Style | Ability to work independently and in teams, manage multiple projects |
Candidates with internship experience in Regulatory Affairs (CMC) are prioritized. You should have a solid understanding of regulatory markets (EU, US, LATAM, APAC, Middle East, Africa, China).
Why This Role Matters
As a Regulatory Associate, you’ll ensure compliance with global standards, supporting life-changing therapies. Your work will impact patients worldwide, aligning with Syneos Health’s mission to innovate in a competitive biopharmaceutical landscape.
Benefits of Joining Syneos Health
We prioritize your growth and well-being with:
- Career Development: Access technical and therapeutic training, peer recognition, and progression opportunities.
- Total Rewards: Competitive salary ($47,000-$79,900 USD), health benefits, 401k match, and flexible PTO.
- Inclusive Culture: Thrive in a diverse, equitable workplace where your voice matters.
- Global Impact: Contribute to trials across 73,000 sites and 675,000+ patients.
How to Apply
Ready to make a difference? Apply by sending your CV to jobs@syneoshealth.com or visit Syneos Health Careers. Not ready? Join our Talent Network for future opportunities. Applications are reviewed on a rolling basis.
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Application Tips
- Highlight regulatory affairs experience, especially in CMC or global submissions.
- Showcase transferable skills if transitioning from related roles.
- Ensure your CV reflects strong analytical and project management abilities.
- Apply promptly to secure your spot in this dynamic role.
About Syneos Health
Syneos Health is a leading biopharmaceutical solutions organization, accelerating customer success through integrated clinical, medical, and commercial insights. Learn more at Syneos Health. We’re committed to diversity and compliance with global regulations.
Career Growth Opportunities
At Syneos Health, you’ll grow through:
- Training in regulatory and clinical methodologies.
- Exposure to global trials across diverse therapeutic areas.
- Mentorship from industry experts.
- A clear path to advance beyond your initial role.
Join Our Mission
Be part of a team that challenges the status quo and delivers therapies to patients worldwide. Apply today to shape the future of healthcare with Syneos Health!
Contact Us
For inquiries, email jobs@syneoshealth.com. Explore more roles at Syneos Health Careers. We can’t wait to welcome you to our global team!