Senior CMC Regulatory Consultant (Small Molecules)
Posted Today by RBW Consulting
Negotiable
Undetermined
Remote
United Kingdom
Summary: The Senior CMC Regulatory Consultant (Small Molecules) is a remote, contract-based role focused on providing high-level expertise in regulatory strategies for small molecule products. The position involves collaborating with a team of experts to navigate complex drug development and regulatory challenges, ensuring compliance with global guidelines. This role is ideal for seasoned professionals with extensive experience in CMC regulatory affairs, particularly in small molecules. The contract is interim until the end of September 2026, with a likelihood of renewal after six months.
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
Key Skills:
- 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
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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.