CMC Submission Lead

CMC Submission Lead

12-Month Contract | Remote (Europe)
Pharmaceutical / Biotechnology Sector

Overview

We are supporting a global pharmaceutical and biotechnology organisation seeking an experienced CMC Submission Lead to support a portfolio of regulatory submission activities across development and commercial products.

This contract opportunity will play a critical role in driving CMC submission strategy, coordinating cross-functional stakeholders, and ensuring high-quality submission content is delivered in line with global regulatory requirements.

The successful consultant will work closely with Regulatory Affairs, Regulatory CMC, Quality, Manufacturing, Technical Operations and Development teams to support major regulatory milestones across international markets.

Key Responsibilities

• Lead CMC submission activities for global regulatory filings.
• Coordinate preparation, review and delivery of CMC documentation for regulatory submissions.
• Drive submission readiness across internal and external stakeholders.
• Support IND, IMPD, NDA, BLA and MAA filing activities.
• Manage submission timelines, risks and critical deliverables.
• Lead cross-functional teams to ensure high-quality Module 3 content.
• Support Health Authority information requests and regulatory responses.
• Provide strategic guidance on CMC submission requirements across multiple regions.
• Collaborate with Quality, Manufacturing and Technical Operations teams to ensure submission alignment.
• Support lifecycle management activities, variations and post-approval submissions as required.

Experience Required

• Experience leading or coordinating CMC regulatory submissions.
• Strong understanding of Module 3 documentation and CTD structure.
• Previous support of major regulatory filings (IND, IMPD, NDA, BLA, MAA).
• Experience working within Regulatory Affairs, Regulatory CMC or CMC submission-focused environments.
• Knowledge of global regulatory requirements, including FDA and EMA submissions.
• Ability to coordinate complex projects across multiple functional teams.
• Strong stakeholder management and communication skills.

Desirable Experience

• Biologics
• Biosimilars

Contract Details

• Initial 12-month contract
• Fully remote within Europe
• Competitive daily rate
• Immediate or flexible start
• Extension potential based on programme requirements