CMC Submission Lead
CMC Submission Lead | 12-Month Contract | Fully Remote (Europe)
We are supporting a global pharmaceutical and biotechnology organisation seeking an experienced CMC Submission Lead to support high-profile regulatory submissions across both development-stage and commercial products.
This role will be responsible for leading and coordinating CMC submission activities, ensuring the successful preparation, review, and delivery of high-quality regulatory dossiers to global Health Authorities. Working within a cross-functional environment, you will collaborate closely with Regulatory Affairs, Regulatory CMC, Quality, Manufacturing, Technical Operations, and Product Development teams to drive submission readiness and meet key programme milestones.
Key Responsibilities
- Lead CMC submission strategy and execution for global regulatory filings.
- Coordinate the preparation, review, and delivery of Module 3 documentation.
- Drive submission readiness activities across internal and external stakeholders.
- Support major submissions including INDs, IMPDs, NDAs, BLAs, and MAAs.
- Manage submission timelines, risks, dependencies, and critical deliverables.
- Coordinate responses to Health Authority questions and information requests.
- Provide regulatory CMC guidance on global submission requirements.
- Support lifecycle management activities, variations, and post-approval changes.
Requirements
- Proven experience leading or coordinating CMC regulatory submissions.
- Strong knowledge of CTD structure and Module 3 content.
- Experience supporting FDA, EMA, and global regulatory filings.
- Background within Regulatory Affairs, Regulatory CMC, or submission management.
- Excellent stakeholder management and cross-functional project leadership skills.
- Ability to operate independently within complex, fast-paced environments.
Preferred Background Candidates may currently operate as a CMC Submission Lead, Regulatory CMC Consultant, Regulatory Affairs CMC Manager, Regulatory Project Lead, Senior Regulatory Writer, Associate Director Regulatory CMC, or Director Regulatory CMC.
Desirable Expertise Experience supporting biologics, biosimilars, or other complex products would be advantageous.
Contract Details
- Initial 12-month contract
- Fully remote across Europe
- Competitive daily rate
- Flexible start date
- Strong likelihood of extension
This is an excellent opportunity to join a global organisation and play a key role in delivering critical regulatory submissions across an international product portfolio.
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