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
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