Note: The job is a remote job and is open to candidates in USA. Walker Cole International is supporting a growth-stage biopharmaceutical company seeking a senior regulatory leader to head its regulatory function. The role owns global regulatory strategy for a small-molecule portfolio, with a focus on CMC, and leads the team through development and commercial readiness while advising senior leadership.

Responsibilities

• Set and own global regulatory strategy across development programs, aligned with clinical, technical and commercial plans
• Lead CMC regulatory strategy, including filing plans, dossier authorship and review, lifecycle management and oversight of external manufacturing partners
• Oversee clinical regulatory activity, including IND and protocol review, and integration of clinical data into submissions
• Direct submission planning and execution to eCTD standards
• Lead health authority engagement, from pre-submission meetings through formal correspondence
• Manage post-approval regulatory obligations, including variations, labeling and periodic reporting
• Advise senior leadership on regulatory risk and feasibility
• Develop regulatory operations, procedures and team capability as the organization grows

Skills

• 15+ years in regulatory affairs within pharma or biotech, with significant time in senior sponsor-side leadership
• Strong CMC regulatory background in small molecule development
• Experience leading integrated CMC and clinical regulatory teams
• Direct involvement in at least one successful approval submission (NDA, MAA or equivalent)
• Post-approval experience, including change management and labeling
• Advanced scientific degree preferred (PhD or equivalent)
• Experience in a high-growth or emerging company is advantageous

Company Overview

• Walker Cole International offers Executive Search, Talent and Interim solutions to the Pharmaceutical, Life Science and Digital Health industries. It was founded in 2020, and is headquartered in London, England, GB, with a workforce of 11-50 employees. Its website is http://www.walkercole.com.