Syneos Health Hiring Regulatory Consultant | ROW Market & CMC Module 3 Experience Required

Syneos Health Hiring Regulatory Consultant (ROW Market & CMC Module 3 Experience)

Syneos Health is hiring experienced professionals for the position of Regulatory Consultant. Candidates with expertise in ROW markets, CMC Module 3, post-approval variations, RTQs, API & Drug Product variations, and site transfer activities are encouraged to apply.

This is an excellent opportunity for regulatory affairs professionals looking to work with a leading global clinical and commercial solutions organization.

Job Overview

• Position: Regulatory Consultant
• Experience Required: 6–9 Years
• Industry: Regulatory Affairs / Pharma / Life Sciences
• Key Expertise: ROW Markets, CMC Module 3, Post-Approval Variations, RTQs
• Company: Syneos Health

Key Skills Required

• Experience in ROW market submissions
• Strong knowledge of CMC – Module 3
• Hands-on experience in:
  • Post-approval variations
  • Responding to Health Authority Questions (RTQs)
  • API & Drug Product variations
  • Site transfer activities
• Ability to work independently and collaborate with cross-functional teams

Job Responsibilities

• Conduct regulatory research and gap analysis for global and regional submissions
• Prepare and support regulatory submission packages including IND, NDA, MAA, CTD, and post-approval submissions
• Manage regulatory activities according to project timelines and strategies
• Support multidisciplinary project teams across the product lifecycle
• Provide troubleshooting support and regulatory guidance to team members
• Prepare estimates and proposals for regulatory services
• Participate in client meetings and business development activities
• Ensure compliance with global regulatory requirements and internal SOPs
• Support audits, cross-functional initiatives, and process documentation
• Maintain training records and complete assigned training requirements

Qualification Requirements

• BS or PhD degree in a science-related field or equivalent experience
• Experience in preparing regulatory submissions and electronic submissions
• Strong written and verbal communication skills
• Good analytical, quality management, and problem-solving skills
• Proficiency in Microsoft Office Applications
• Ability to manage multiple projects simultaneously
• Fluent in English communication

Why Join Syneos Health?

At Syneos Health, employees work in a collaborative and inclusive environment focused on innovation and patient impact. The company offers:

• Career development and progression opportunities
• Technical and therapeutic area training
• Peer recognition and rewards programs
• Inclusive and supportive work culture
• Opportunity to work with global healthcare innovators

How to Apply

Interested candidates can explore opportunities and apply through the official careers portal of Syneos Health.