Job Type: Full Time, Hybrid, Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Regulatory Affairs, Regulatory Writing, Regulatory Compliance, Global Submissions, eCTD, IND/NDA/BLA Submissions, ICH-GCP, Regulatory Strategy, Regulatory Intelligence, Labeling Strategy.

Job Title: Regulatory Senior Consultant

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Pharmaceutical

Pharmaceuticals & Biotech

Job

Company: Syneos Health

Location: Gurugram, India (Hybrid)

Job ID: 25107708

Employment Type: Full-time

Department: Clinical Solutions – Regulatory Affairs

Experience Required: 8+ years of experience in Regulatory Affairs with solid expertise in CMC regulatory submissions, CTD/eCTD documentation, post-approval variations, and lifecycle management activities.

Education: Master’s degree in Pharmacy (M.Pharm) or equivalent qualification in Pharmaceutical Sciences, Life Sciences, or related field.

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Company News

Manager

Consulting

Compensation & Benefits

Pharmacy

Business & Corporate Law

Salary Package:



₹20–35 LPA (Estimated as per current market standards for Regulatory Senior Consultant roles in India; final compensation depends on regulatory expertise, therapeutic experience, market exposure, and interview performance.)

Role Summary

The Regulatory Senior Consultant will independently manage regulatory activities, support global submissions, provide regulatory strategy expertise, and ensure compliance with global health authority requirements across product development and lifecycle management activities.

Key Responsibilities

Regulatory Submission Management

Prepare and manage regulatory submissions for global markets.
Support:
IND submissions
NDA/MAA submissions
CTD/eCTD dossiers
Post-approval variations
Lifecycle management activities
Conduct regulatory research and gap assessments based on global requirements.
Prepare regulatory strategies, submission plans, and product development documents.
CMC Regulatory Expertise

Author and review CMC Module 3

📌 Regulatory Senior Consultant (Gurugram)
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