π Exciting opportunity at a fast-growing biotech π
The team are looking for a regulatory affairs scientific lead that has excellent knowledge and skills in CMC, GMP and regulatory affairs.
Responsibilities:
• Lead the implementation of regulatory strategies to handle agency inquiries, oversee product lifecycle management and manage dossier remediation.
• Provide expert guidance on regulatory strategies, processes, filings, and best practices, with a focus on CMC for NADA products.
• Display in-depth scientific knowledge and lead the Regulatory CMC Remediation Team.
• Assess change controls for regulatory impact and manage communications with authorities under Senior US RA Management guidance.
• Create regulatory documentation for project submissions and stay updated on regulatory changes to advise teams.
• Assess change controls for regulatory impact and manage communications with authorities under Senior US RA Management guidance.
Ideal Candidate:
• Good understanding of GMP requisites, particularly in the domain of chemistry, manufacturing, and controls (CMC).
• Extensive experience in US regulatory affairs with a specialized focus on CMC.
• Holds a science degree or other relevant life sciences experience.
If interested please apply direct or contact: rhys.rowberry@cpl.com
