Associate Director, Regulatory Affairs

Location: Chiswick, London, UK / Remote, UK; hybrid workplace.

Company

hirify.global partners with biopharmaceutical sponsors through clinical trial delivery, home health services, expanded access programs, and market access consultancy.

What you will do

• Develop and lead regulatory strategies for global Expanded Access Programs, Open Label Extensions, and Post-Approval Named Patient Programs.
• Provide regulatory operational oversight and guidance covering US, EU, UK, and rest-of-world requirements.
• Oversee global, regional, and multi-country strategies, regulatory reviews, approvals, and license maintenance.
• Interact with regulatory authorities and provide guidance for internal project teams.
• Lead, train, and develop Regulatory Affairs staff.
• Build client relationships and support proposals, bid defenses, and capability presentations.

Requirements

• Bachelor’s degree in law, life sciences, or a related scientific discipline.
• 7+ years of broad regulatory experience.
• Experience developing regulatory strategy.
• Exposure to Expanded Access, Compassionate Use, Open Label Extension, or Post-Approval Named Patient Programs.
• Strong verbal and written communication, organization, attention to detail, and Microsoft Office skills.
• Ability to manage confidential information and multiple deadlines with a high level of accuracy.

Culture & Benefits

• Private medical insurance, life assurance, critical illness cover, and income protection.
• Salary sacrifice pension scheme.
• Enhanced maternity and paternity pay.
• Educational assistance allowance and a paid volunteering day.
• Inclusive, supportive environment focused on integrity, accountability, wellness, growth, and professional development.

Hiring process

• Submit a resume in English through the hirify.global Careers Portal or LinkedIn Easy Apply.
• An Upwage AI screener may be used during the application process, followed by contact from the hirify.global team if selected.