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Regulatory Affairs Scientific Leader

2 months ago

London, United Kingdom Hobson Prior Full time

Hobson Prior is seeking a CMC Lead for Regulatory Affairs. This role will focus on leading a team in the field of gene therapy, reporting to the Vice President of Regulatory Affairs. The successful candidate will be responsible for developing and implementing regulatory strategies across all gene therapy projects, identifying and managing regulatory risks, and maintaining relationships with external regulatory professionals.
Lead a team focused on global regulatory affairs in gene therapy.
Develop and implement regulatory strategies for gene therapy projects.
Identify and manage regulatory risks.
Maintain relationships with external regulatory professionals.
Collaborate with internal teams to develop robust regulatory strategies.
Plan, manage, and review regulatory submissions.
Provide regulatory expertise and serve as an internal consultant on relevant regulations and guidelines.
Manage and coordinate regulatory workflow and budget for consultants and vendors.
Advanced degree in a scientific discipline.
Experience in the pharmaceutical/biotechnology industry.
Knowledge of regulatory affairs CMC, specifically gene therapy products or complex biologics.
Familiarity with regulatory environments including FDA, EMA, and ICH.
Experience in preparing and successfully submitting CMC regulatory submissions in key ICH regions.
Ability to represent the regulatory affairs group in project teams, committees, and external meetings.
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