Syneos Health, a leading fully integrated biopharmaceutical solutions organization, is hiring a Regulatory / Sr Regulatory Associate for Module 1 regulatory submissions. This is a home-based opportunity in India, ideal for professionals with 2-4 years of regulatory experience and expertise in Veeva Vault and RIMS.
About Syneos Health
Syneos Health accelerates customer success by seamlessly integrating clinical, commercial, and consulting expertise. With 29,000+ employees across 110 countries, we are committed to bringing life-changing therapies to patients faster. Our Total Self culture fosters inclusivity, career growth, and innovation, making Syneos Health a great place to work.
Key Responsibilities
- Interpret health authority approval letters and update registration data for marketed/investigational products.
- Process intake, archival, and extraction of regulatory data from health authority correspondence.
- Ensure accurate data entry into RIM systems, linking submissions with correct applications.
- Coordinate data reviews with stakeholders, ensuring compliance with reporting timelines.
- Identify and escalate non-compliance or quality issues to the Regulatory Information Management team.
- Support training and mentoring of junior team members.
- Assist in client meetings and maintain strong client relationships.
Qualifications & Skills
- 2-4 years of regulatory experience (pharma/biotech/CRO).
- Minimum 2 years of hands-on experience with Veeva Vault and RIMS.
- Bachelor’s degree (BS/BA) or equivalent experience.
- Strong analytical skills with attention to detail.
- Proficient in Microsoft Office (Word, Excel, PowerPoint).
- Excellent communication and interpersonal skills.
- Ability to work independently and manage multiple projects.
- Fluent in English (written & spoken).
Why Join Syneos Health?
✅ Career Growth: Continuous learning & development opportunities.
✅ Global Impact: Work on 94% of FDA-approved novel drugs & 95% of EMA-authorized products.
✅ Inclusive Culture: A workplace that values diversity and authenticity.
✅ Flexible Work: Home-based role with a supportive team.
How to Apply
📌 Job ID: 25003476
📍 Location: India (Home-Based)
