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Regulatory Consultant – Row Markets & Cmc Module 3 Specialist

Syneos Health
Syneos Health
6-9 years
Not Disclosed
Remote, India, India
2 May 11, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing

Regulatory Consultant – ROW Markets & CMC Module 3 Specialist

Company: Syneos Health
Job Title: Regulatory Consultant (ROW Market Experience & CMC Module 3 Experience)
Location: Remote – India
Job ID: 25108389
Department: Regulatory Affairs / Clinical Solutions


About the Role

Syneos Health is hiring a Regulatory Consultant with expertise in ROW (Rest of World) Markets, CMC Module 3 Documentation, Post-Approval Variations, and Regulatory Submissions.

This remote opportunity is ideal for professionals experienced in Regulatory Affairs, Global Submissions, API & Drug Product Variations, Health Authority Responses, and Product Lifecycle Management within the pharmaceutical or life sciences industry.

The selected candidate will support regulatory strategy, submission preparation, lifecycle management, and cross-functional regulatory operations for global pharmaceutical products.

This opportunity is best suited for candidates with 6–9 years of Regulatory Affairs experience.


Key Responsibilities

Regulatory Submissions & Lifecycle Management

  • Prepare and manage regulatory submissions for:
    • IND
    • NDA
    • MAA
    • PMA
    • CTD and eCTD submissions
  • Contribute to pre-approval and post-approval regulatory activities
  • Support product registration applications and maintenance activities
  • Prepare briefing packages for Health Authority meetings and scientific advice interactions

CMC Module 3 & Variation Management

  • Handle CMC Module 3 documentation and submission activities
  • Manage:
    • API variations
    • Drug Product variations
    • Site transfer submissions
    • Post-approval variations
  • Respond to Health Authority Questions (RTQs)
  • Conduct gap analysis and regulatory research based on regional and global requirements

Regulatory Strategy & Cross-Functional Collaboration

  • Participate in multidisciplinary project teams involving:
    • Clinical teams
    • Technical experts
    • Regulatory stakeholders
  • Support product development throughout the lifecycle
  • Provide regulatory guidance and troubleshooting support to project teams
  • Collaborate independently and across functions to ensure timely project delivery

Project & Client Management

  • Manage day-to-day regulatory activities according to:
    • Timelines
    • Scope
    • Budgets
    • Regulatory strategies
  • Prepare regulatory service estimates for proposals and business development activities
  • Participate in client meetings and project discussions
  • Support internal and external project audits

Compliance & Process Improvement

  • Ensure compliance with:
    • Global regulatory requirements
    • Company SOPs
    • Regulatory policies and procedures
  • Support creation and maintenance of SOPs and process documentation
  • Prepare training materials and share regulatory best practices
  • Maintain required training records and compliance documentation

Educational Qualification

Candidates should possess:

  • BS Degree
    OR
  • PhD Degree

Preferably in:

  • Life Sciences
  • Pharmacy
  • Regulatory Affairs
  • Medical Writing
  • Scientific or Healthcare-related disciplines

Required Experience

  • 6 to 9 years of experience in:
    • Regulatory Affairs
    • CMC Documentation
    • ROW Market Submissions
    • Regulatory Lifecycle Management
    • Global Regulatory Operations

Mandatory Experience Areas

  • ROW market regulatory experience
  • CMC Module 3 expertise
  • Post-approval variations
  • Health Authority RTQ responses
  • API & Drug Product variation management
  • Site transfer submissions