Job Title: Regulatory Senior Consultant
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 strong 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.
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 sections for regulatory submissions.
Support CMC documentation for:
New product registrations
Post-approval changes
Regulatory maintenance activities
Ensure compliance with regional regulatory expectations.
Regulatory Agency Interaction
Prepare briefing packages for regulatory agency meetings.
Support scientific advice meetings and health authority interactions.
Provide regulatory input during cross-functional project discussions.
Address regulatory queries and provide strategic recommendations.
Project & Stakeholder Management
Manage day-to-day regulatory activities according to:
Project timelines
Scope
Budget requirements
Regulatory strategies
Collaborate with:
Clinical teams
CMC teams
Medical writing teams
Quality teams
Global regulatory stakeholders
Act as a regulatory subject matter expert for project teams.
Quality & Compliance
Ensure adherence to:
Global regulatory guidelines
Company SOPs
Quality management systems
Support regulatory audits and inspection readiness activities.
Develop SOPs, process documents, and regulatory best practices.
Maintain training records and complete required compliance training.
Required Technical Skills
Regulatory Affairs Management
CMC Module 3 Authoring
CTD/eCTD Submissions
IND/NDA/MAA Regulatory Documentation
Post-Approval Variations
Lifecycle Management
Regulatory Strategy Development
Health Authority Interactions
Global Regulatory Guidelines
EU Regulatory Affairs
GCC Market Regulatory Experience
Pharmaceutical Product Development Knowledge
Preferred Market Experience
European Union (EU) Regulatory Submissions
GCC Regulatory Markets
Global Pharmaceutical Submissions
Complex and Non-complex Regulatory Applications
Qualification Requirements
Master’s degree in Pharmacy (M.Pharm) preferred.
Strong pharmaceutical regulatory experience.
Experience in preparation and review of technical regulatory documents.
Excellent written and verbal communication skills.
Strong analytical and problem-solving abilities.
Ability to manage multiple projects independently.
Key Competencies
Regulatory strategy mindset
Attention to detail
Stakeholder management
Client-facing communication
Project management skills
Quality-focused approach
Ability to work independently in a global environment
Work Location
Gurugram, India (Hybrid)
About Syneos Health
Syneos Health is a global life sciences organization providing clinical development and commercialization solutions. The company supports pharmaceutical and biotechnology organizations across the drug development lifecycle, helping accelerate delivery of innovative therapies to patients.
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