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Syneos Health® is a leading, fully integrated biopharmaceutical solutions provider with over 29,000 employees across 110 countries. By fusing clinical development, medical affairs, and commercial capabilities, Syneos accelerates customer success and patient access to therapies. Whether you work in Full-Service or FSP (Functional Service Provider) roles, you become a part of something truly impactful.
Why Work at Syneos Health?
- Total Self Culture: Be your authentic self.
- Global Collaboration: Diverse thoughts, backgrounds, and cultures are celebrated.
- Career Development: Structured learning and growth pathways.
- Recognition & Rewards: Peer recognition and performance-based incentives.
📌 Job Details: Regulatory Associate (EU Market) – India (Remote)
- Job ID: 25100207
- Location: Remote, India
- Department: Global Regulatory Affairs
- Market Focus: EU
📋 Job Responsibilities
- Prepare and review global CMC dossiers, variation applications, and post-approval changes.
- Assist in submission of documents like INDs, NDAs, MAAs, DMFs, renewals, marketing authorization transfers, etc.
- Conduct regulatory research to identify precedents and support orphan drug designations.
- Perform quality checks, compile regulatory data, and assist with detailed reporting.
- Collaborate cross-functionally to support regulatory strategies globally (EU, US, LATAM, APAC, MEA, China).
- Maintain knowledge of current global regulatory guidelines and frameworks.
✅ Eligibility Criteria
Education:
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- Master’s in Pharmacy (M.Pharm preferred)
- Or Master’s in Science / Healthcare or equivalent
Experience:
- Minimum 1 year of experience in Regulatory Affairs (Global/CMC)
- Candidates with relevant Regulatory Affairs internships will be preferred
Skills Required:
- Strong knowledge of EU regulatory market
- Proficiency in Microsoft Office tools
- Excellent communication and analytical skills
- Ability to multi-task across projects
- Fluency in written and spoken English
🎁 Employee Benefits at Syneos Health
- Flexible remote work environment
- Global exposure across 110+ countries
- Employee development & leadership programs
- Total rewards and peer recognition initiatives
- Inclusive work culture under Total Self Policy
📝 How to Apply
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