
Syneos Health®
Regulatory Associate
Location: Pune, India
Job ID: 25003844-4
Position: Regulatory Associate
Syneos Health®, a global leader in biopharmaceutical solutions, is inviting applications for the role of Regulatory Associate at its Pune location. This is an excellent opportunity for professionals with regulatory affairs experience to contribute to a dynamic and globally impactful organization that is dedicated to accelerating the delivery of life-changing therapies.
🧬 About Syneos Health
Syneos Health is a fully integrated biopharmaceutical solutions company, operating in over 110 countries with a global team of 29,000 employees. The company combines clinical development, medical affairs, and commercial capabilities into a singular, powerful model that focuses on achieving customer success and improving patient outcomes.
Whether part of a Functional Service Provider (FSP) model or full-service collaboration, Syneos Health thrives on innovation, agility, and the spirit of problem-solving.
⭐ Why Work at Syneos Health?
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🚀 Career Growth: Continuous training and clear career progression pathways.
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🤝 Supportive Culture: Line management that supports, mentors, and engages.
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🌍 Inclusive Environment: Embracing diversity through its Total Self culture.
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💡 Employee Recognition: Comprehensive rewards and peer acknowledgment programs.
Syneos Health fosters an environment where you can bring your authentic self to work, ensuring personal and professional growth in a collaborative atmosphere.
📌 Key Responsibilities
As a Regulatory Associate, you will:
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Assist in preparing regulatory submission documents for INDs, NDAs/MAAs, DMFs, and more.
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Support clinical development planning and conduct regulatory gap analyses.
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Contribute to orphan drug designation applications through detailed regulatory research.
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Utilize regulatory systems such as Veeva, DMS, or RIMS for document and data management.
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Perform quality checks on documentation to ensure compliance with global standards.
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Gather, compile, analyze, and report data for regulatory needs.
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Assist internal teams and clients with regulatory research and document submission.
✅ Candidate Profile
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🎓 Educational Qualification: Master’s degree in a science or healthcare field (or equivalent).
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🧪 Experience: Minimum of 2 years in regulatory affairs.
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🌍 Regional Exposure: Experience with EU, US, or ROW regulatory submissions preferred.
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💻 Technical Skills: Proficiency in Veeva, DMS, or RIMS systems.
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🗣️ Communication: Strong written and verbal communication skills.
This is your chance to join a company where your work truly makes a difference—not just in your career, but in the lives of patients across the world. At Syneos Health, you will be part of a diverse team that’s passionate about innovation, integrity, and impact.
If you’re ready to grow in a fast-paced, rewarding environment and make a real difference in global healthcare—apply now for the Regulatory Associate position at Syneos Health, Pune.
To apply for this job please visit www.syneoshealth.com.