Senior CMC Regulatory Consultant (Small Molecules)

Job description

Senior CMC Regulatory Consultant (Small Molecules)

Interim until end Sept 2026 – 6 month renewal likely.

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.

Extra information

Status

Closed

Education Level

Secondary School

Location

United Kingdom

Type of Contract

Full-time jobs

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English