PHARMAFull-time
Regulatory Consultant (CMC-EU, GCC & AU)
REMOTE (IN)REMOTEPOSTED: 9/27/2026
PHARMAFull-time
HIRING ORGANIZATIONSYNEOS HEALTHBiopharmaceutical / Healthcare Services
ROLE OVERVIEW
Lead CMC regulatory authoring, lifecycle management, and global submissions across EU, GCC, and AU markets.
ROLE DEFINITION & RESPONSIBILITIES
- •Conduct research of existing product data relative to global or regional regulatory requirements
- •Prepare administrative and technical components of regulatory agency submissions (CTD Module 3)
- •Manage delivery of day-to-day regulatory activities for assigned projects
- •Participate as regulatory support on multidisciplinary project teams
- •Act as a subject matter expert and help team members with troubleshooting
- •Ensure compliance with global regulatory requirements and company policies
Reporting Hierarchy: Reports to Regulatory Affairs Director • Individual Contributor
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Extensive experience in CMC authoring and independently authoring CTD Module 3 sections
- Experience with post-approval variations/supplements
- Cross-functional interaction with analytical, formulation, and manufacturing teams
- CMC writing and lifecycle management for small molecules
- Experience across EU, USFDA, AU, GCC, or ROW markets
PREFERRED QUALIFICATIONS
- •Experience across multiple regulatory regions (EU, USFDA, AU, GCC)
- •Familiarity with scientific advice and agency interactions
- •Prior experience in a Contract Research Organization (CRO) or pharmaceutical environment
REQUIRED VERIFIED SKILLS
CMC Authoring
CTD Module 3
Regulatory Submissions
Lifecycle Management
Small Molecules
Post-Approval Variations
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Health insurance, retirement benefits, career development, total rewards program
Competitive market-aligned salary package commensurate with experience in regulatory affairs and CMC writing.
ORGANIZATION CONTEXT & CULTURE
Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success across the drug development continuum.
TEAM SIZE: 25,000+ employees
INDUSTRY: Biopharmaceutical / Healthcare Services
Culture: Syneos Health is committed to building an inclusive culture where colleagues can authentically be themselves and drive impact.
EXPECTED CAREER ROADMAP
Clear career growth pathways into Senior Regulatory Manager or Director roles within global regulatory affairs.
APPLICATION ADVISORY
Highlight your independent CMC authoring experience and specific familiarity with CTD Module 3 sections in your application.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.