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๐ Syneos Health — Associate RA (Module 1, Regulatory Submission) | Remote / Gurugram (India)
Company: Syneos Health®
Role: Associate Regulatory Affairs — Module 1 (Regulatory Submission)
Location: Remote (Exception) / Gurugram (Hybrid), India
Requisition ID: 25100921 (posted today)
If you’re an early-career regulatory professional who enjoys the detail and discipline of submission work, Syneos Health is hiring an Associate RA focused on Module 1 (country-specific administrative components) and lifecycle regulatory activities. This role is a great fit for candidates who want hands-on exposure to INDs/NDAs/MAAs, regulatory trackers, and Health Authority interactions.
๐ What you’ll do
- Support preparation of Module 1 documentation and country-specific administrative forms.
- Assist with regulatory submissions (INDs, NDAs/MAAs, DMFs, variations, renewals, MATs) and prepare responses to Health Authority queries.
- Maintain submission trackers, timelines, and status reports; ensure compliant archiving of submission documents according to SOPs.
- Conduct regulatory research to support submission strategy (e.g., orphan drug precedents).
- Coordinate with internal stakeholders and clients to gather information and deliver accurate submission packages.
๐ฏ Who should apply
- Education: Master’s in Pharmaceutical Sciences (or related life science).
- Experience: ~2 years in regulatory affairs, quality, or document management support roles.
- Strong written/verbal communication and advanced MS Office skills.
- Detail-oriented, comfortable with timelines and cross-functional coordination.
๐ฐ Salary estimate (India)
Based on market-reported salary data for Regulatory Affairs Associate roles at Syneos Health in India, a reasonable expectation is:
Approx ₹3.0 – ₹6.6 LPA (typical range; average ~₹4.0–4.9 LPA) — figures are derived from employee-reported salary data on Glassdoor and major job market aggregators.
Note: actual offer depends on experience, exact responsibilities, location, and internal banding. Use the range above as a guideline when negotiating.
๐ Why this role matters
Working at Syneos Health gives you exposure to global regulatory submissions and client-facing CRO activities. This job helps you build a solid foundation in submission assembly, timelines management, and regulatory communications — skills that accelerate a regulatory career in pharma and biotech.
✅ How to apply & follow up
- Apply - Click here
- After applying, email a short note and your application reference to charu.soni@syneoshealth.com — put “Associate RA (Module 1)” in the subject line so the hiring team can triage your application faster.
Tip: In your follow-up email include 2–3 lines highlighting any direct submission or Module-1 experience and attach your CV (PDF).
๐ฉ Final note
If you’re meticulous, enjoy regulatory detail, and want to grow in a global CRO environment, this is a solid opportunity. Apply and follow up with Charu Soni to make sure your application gets noticed.
Not a recruiter — just sharing a live opening for regulatory professionals.
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