Job Title: Associate Regulatory Affairs (Module 3, CMC)
Date Updated: 08 August 2025
Location: India – Gurugram – Hybrid
Job ID: 25100545
Employment Type: Full-time
About the Company:
Syneos Health® is a leading, fully integrated biopharmaceutical solutions provider operating across 110+ countries with 29,000 employees. The company partners with life sciences organizations to accelerate clinical development, regulatory submissions, and commercialization. Over the past five years, Syneos Health has been involved in 94% of FDA-approved novel drugs, 95% of EMA-authorized products, and over 200 studies involving 73,000 sites and 675,000+ trial patients.
Role Overview:
This role focuses on the preparation and submission of Module 3 (CMC) regulatory documents for post-approval variations, renewals, and lifecycle management activities. The Associate RA will work independently on non-complex submissions and with senior guidance for complex projects. The role also involves regulatory systems management, quality control, project coordination, and client interaction.
Key Responsibilities:
Prepare Module 3 sections for CMC variations, renewals, legal entity name changes, and other lifecycle maintenance activities.
Prepare and submit IND, marketing, and lifecycle maintenance applications in compliance with regulatory guidelines.
Perform activities in regulatory information management systems (e.g., Veeva RIMS) including creation of objectives and submission content plans.
Process regulatory information with high accuracy under tight timelines according to SOPs.
Maintain regulatory databases, logs, and records per client and company requirements.
Conduct quality control reviews of documents, manage review cycles, and track to final submission.
Attend client meetings and contribute to building strong client relationships.
Review and track work of junior or peer team members, coordinating with project managers and directors.
Identify workload risks, escalate appropriately, and propose solutions for non-complex issues.
Support training and mentoring of team members when required.
Maintain personal and project training records, ensuring completion of required training.
Qualifications & Skills:
MS/M.Pharm or equivalent education/experience.
Minimum 6 months’ experience for Regulatory Associate; 1.5+ years for Senior Regulatory Associate.
Excellent communication and interpersonal skills.
Advanced Microsoft Office proficiency.
Experience with RIM systems such as Veeva RIMS and Trackwise preferred.
Strong analytical and organizational skills.
Ability to work independently, follow detailed instructions, and interact with multiple departments.
Ability to manage multiple concurrent projects with differing requirements.
Fluent in written and spoken English.
Culture & Benefits:
Career growth through technical and therapeutic training.
Supportive management and recognition programs.
“Total Self” culture promoting authenticity, inclusion, and belonging.
Gujarat :
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Siliguri |Illinois :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
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Kyiv |Lima Region :
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