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Syneos Health, a global leader in biopharmaceutical solutions, is inviting applications for the position of Regulatory Associate (EU Market). This is a remote-based opportunity in India, ideal for professionals with a passion for regulatory affairs and a desire to work in a dynamic, globally connected environment.
About Syneos Health
With over 29,000 employees across 110 countries, Syneos Health delivers integrated clinical, medical, and commercial services to accelerate the development and delivery of life-changing therapies. Their culture centers around innovation, inclusion, and driving outcomes that matter.
Position: Regulatory Associate (EU Market)
- Location: Remote (India)
- Job ID: 25100207
- Department: Regulatory Affairs
- Work Type: Full-time
Key Responsibilities
- Prepare and review global regulatory submissions, including CMC dossiers, variation applications, and post-approval changes.
- Support product development activities, including gap analyses and clinical development plans.
- Ensure compliance with regulatory guidelines across global markets including EU, US, LATAM, APAC, Middle East, Africa, and China.
- Conduct regulatory research, identify precedents, and support submissions like orphan drug designation requests.
- Perform quality checks on regulatory documentation.
- Assist in the submission of regulatory documents, coordination with internal teams, and general regulatory support activities.
Required Qualifications
- Minimum 1 year of experience in Global Regulatory Affairs (preferably CMC-focused).
- Experience with global CMC dossier preparation, regulatory lifecycle activities, and variation submissions.
- Familiarity with EU regulatory frameworks.
- Candidates with Regulatory Affairs internships will be given preference.
- Proficient in Microsoft Office with strong attention to detail and analytical skills.
- Excellent communication skills in English.
Educational Background
- Master’s in Pharmacy (M.Pharm) preferred, or a Master’s degree in Science/ Healthcare or an equivalent qualification.
Why Join Syneos Health?
- Work in a company where “Work Here Matters Everywhere” is more than a slogan.
- Be part of a supportive team committed to diversity, equity, and inclusion.
- Access continuous learning, career growth, and a rewarding work culture.
- Collaborate with industry leaders and work on meaningful global regulatory projects.
How to Apply?
To apply, visit the official Syneos Health Careers Page and search for Job ID: 25100207 or look under Regulatory Associate – EU Market in the India (Remote) listings.
