Overview

Reference Number: JO-2402-530393
Senior Regulatory Affairs Scientific Leader
Rate: Negotiable
Job Type: Permanent
Location: United States

🌟 Exciting opportunity at a fast-growing biotech 🌟

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