Senior Regulatory CMC Consultant

Senior CMC Regulatory Consultant (Small Molecules)

Interim until end Sept 2026 – 6 month renewal ongoing. 

Remote

Are you a seasoned CMC Regulatory Affairs professional with expertise in small molecules? Are you ready to bring your knowledge and experience to a dynamic role where you can work remotely on impactful projects? If so, we have the perfect opportunity for you!

We are seeking a Senior CMC Regulatory Consultant specializing in small molecules. This is a contract-based, remote position offering flexibility and the chance to make a significant impact in a thriving area of the regulatory landscape. You will join a team of experts, collaborating on intricate drug development and regulatory strategies, enabling compliance and smooth submissions in today’s highly regulated environment.

Key Responsibilities:

• Provide high-level expertise in CMC regulatory strategies for small molecule products
• Prepare, review, and deliver regulatory documentation to support product development, submissions, and lifecycle management
• Offer regulatory guidance to cross-functional project teams, ensuring compliance with global CMC guidelines and standards
• Troubleshoot and address complex regulatory challenges while maintaining timelines and quality
• Serve as a key contributor during regulatory agency interactions, offering insights and strategies

What We’re Looking For

• A strong background in Regulatory Affairs with a specific focus on Regs CMC and small molecules (10+ years specifically in small molecule regulatory CMC activities)
• Proven experience in preparing and managing regulatory submissions aligned with global health authorities
• An independent, proactive problem-solver with excellent communication and organizational skills
• Adept at navigating the complexities of remote collaboration with international teams

regulatory, CMC, small, molecule, RA, affairs, pharmaceutical, strategy, lifecycle.