Director, Regulatory Affairs (Biotech)

Location: Remote opportunity within the United Kingdom, with occasional travel or attendance expectations at the London office.

Annual base salary: £111,100–£141,800, plus annual bonus, equity compensation, and comprehensive benefits.

Company

hirify.global is a clinical-stage TechBio company using AI, biology, chemistry, and clinical development to discover and develop medicines for areas of significant unmet need.

What you will do

• Lead global regulatory strategies and activities across applicable jurisdictions, including the EU, US, and UK, throughout development and post-approval stages.
• Support clinical programs and product teams by managing day-to-day regulatory activities, guidance, and strategic implementation.
• Coordinate multiple regulatory projects and assess immediate and long-term risks for assigned programs.
• Develop and execute regulatory submissions, including clinical trial applications, marketing authorization applications, orphan drug designations, pediatric submissions, and breakthrough designations.
• Collaborate with clinical, commercial, medical affairs, strategic operations, toxicology, pharmacology, and clinical development stakeholders.
• Lead interactions with health authorities and external stakeholders, interpret regulatory guidelines, and communicate impact assessments.

Requirements

• At least 10 years of experience in the pharmaceutical industry, including at least 8 years in global regulatory affairs.
• Mandatory experience with major health authorities, including the US FDA, Health Canada, UK MHRA, and EMA.
• At least 8 years of experience with regulatory submissions such as INDs, NDAs/NDS/MAAs, post-marketing measures, PIPs/PSPs, ODD, BTD, and EU PRIME activities.
• Strong understanding of regulatory strategy and operational implementation.
• Demonstrated management, communication, negotiation, interpersonal, organizational, and problem-solving skills.
• Experience working cross-functionally and with global teams.

Nice to have

• Experience in oncology, rare disease, or immunology and inflammation.

Culture & Benefits

• Remote-friendly work arrangement with most work conducted from home.
• Annual bonus and equity compensation.
• Comprehensive employee benefits package.
• Values centered on integrity, accountability, active learning, urgency, ownership, and cross-functional collaboration.
• Opportunities to attend relevant meetings, seminars, and conferences.