Senior Regulatory CMC Project Lead

Senior Regulatory CMC Project Lead - Interim Late-Stage Small Molecule Development | Global Regulatory Strategy | MAA Preparation

Remote

If based in UK, Outside IR35

Are you a seasoned Regulatory CMC professional looking to take ownership of a high-profile late-stage asset approaching registration?

We're supporting an innovative global pharmaceutical organisation seeking a Senior Regulatory CMC Project Lead to drive regulatory strategy for a key small molecule programme as it advances towards Marketing Authorisation submission.

This is a highly visible position where you'll play a central role in shaping global CMC regulatory strategy, influencing critical development decisions, and working alongside senior scientific, quality, supply chain and regulatory leaders across multiple geographies.

You'll become the strategic Regulatory CMC lead for a late-stage small molecule asset, taking ownership of the global CMC regulatory roadmap and ensuring successful preparation and delivery of the registration dossier.

Working at the heart of a complex global development programme, you'll collaborate with cross-functional teams, lead agency interaction strategies, manage regulatory risk, and help accelerate the path to patients through innovative and pragmatic regulatory approaches.

This is an excellent opportunity for someone who enjoys combining technical CMC expertise with strategic leadership, stakeholder engagement, and regulatory project delivery.

• 10+ years' experience within Regulatory Affairs CMC – focused specifically on small molecule late stage development.
• Proven experience leading the CMC components of global Marketing Authorisation submissions.
• Strong understanding of late-stage development and registration activities for small molecule products.
• Experience developing and executing global regulatory strategies.
• Deep knowledge of FDA, EMA and ICH regulatory requirements.
• Exposure to international markets such as China, Japan, Brazil and Canada would be highly advantageous.
• Demonstrated success working within complex, cross-functional global development teams.
• Excellent project leadership, communication and stakeholder management skills.
• Strong analytical, problem-solving and risk management capabilities.

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