Regulatory Consultant (CMC Module 3)
Syneos Health is seeking a Regulatory Consultant to manage CMC Module 3 documentation and lifecycle activities. The role involves supporting global post-approval submissions and collaborating with cross-functional teams to ensure regulatory compliance. Candidates must have extensive experience in EU regulatory requirements and eCTD submissions for API and Drug Products. This is a remote-friendly position focused on delivering high-quality regulatory outcomes for a global clinical solutions leader.
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Experience
6-12 years
Function
Consulting
Work mode
Remote, unknown
Company
Tier 2
What you will work on
Syneos Health is seeking a Regulatory Consultant to manage CMC Module 3 documentation and lifecycle activities. The role involves supporting global post-approval submissions and collaborating with cross-functional teams to ensure regulatory compliance. Candidates must have extensive experience in EU regulatory requirements and eCTD submissions for API and Drug Products. This is a remote-friendly position focused on delivering high-quality regulatory outcomes for a global clinical solutions leader.
TAL's take
Solid established firm in the life sciences consulting space with clear role expectations and domain-specific requirements.
Very well-defined responsibilities and technical requirements specific to the CMC regulatory domain.
Must haves
- Experience in CMC authoring and review (Module 3)
- Hands-on experience with post-approval lifecycle management
- Expertise in EU regulatory requirements
- Experience in API and Drug Product variations
- Knowledge of eCTD submissions
Tools and skills
About the company
Global contract research organization (CRO) with established presence but not a top-tier tech product company.
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