Senior Regulatory Associate (Sterile Exp – EU Market)
Location: Gurugram, India (Hybrid)
Company: Syneos Health
Experience Required: 4+ Years in EU post-approval variations & sterile submissions
Job Type: Full-Time, Hybrid
Job ID: 25100210
Job Summary
Syneos Health is hiring a Senior Regulatory Associate with hands-on experience in sterile pharmaceutical regulatory submissions for the EU market. This hybrid role in Gurugram involves global post-approval CMC activities, sterile manufacturing compliance, and lifecycle maintenance of regulatory dossiers. Ideal for experienced regulatory professionals seeking a high-impact, globally integrated pharma role.
Key Responsibilities
Prepare and submit full or component regulatory applications (INDs, NDAs, MAAs)
Author and review Modules 2 & 3 focused on sterile manufacturing and microbial control
Lead post-approval variation submissions involving sterile drug product processes
Review and manage submissions for cleanroom classifications, sterilization techniques, and equipment changes
Perform high-quality dossier compilation under regulatory SOPs
Conduct quality control reviews and document tracking
Attend client meetings and support project deliverables
Mentor junior regulatory team members
Maintain regulatory logs and databases
Identify and escalate risks with resolution proposals
Required Skills & Qualifications
4+ years of regulatory experience in EU post-approval variations
Sterile dosage form expertise including aseptic and terminal sterilization
Experience in Module 2 & 3 compilation and review
Strong knowledge of global CMC dossier preparation
Proficient in Microsoft Office Suite
Master’s in Pharmacy or Science preferred
Strong analytical and interpersonal communication skills
Fluent in English (written and verbal)
Ability to manage multiple concurrent regulatory projects
Perks & Benefits
Career growth and technical skill development
Employee recognition and rewards programs
Supportive work environment and leadership
Access to global projects across 110 countries
Work-life balance with hybrid flexibility
Part of a Total Self Culture promoting authenticity and inclusion
Company Description
Syneos Health is a global biopharmaceutical solutions provider operating in over 110 countries. We’ve contributed to 94% of FDA novel drug approvals and offer integrated clinical development, regulatory, and commercialization services, making us a key player in pharma innovation.
Work Mode
Hybrid – Primary location: Gurugram, India
Call to Action
Ready to make an impact in global regulatory affairs? Apply today to join Syneos Health as a Senior Regulatory Associate and accelerate your career in sterile drug compliance and EU submissions.
Apply Now or join our Talent Network to stay informed about upcoming opportunities.
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