EU Regulatory Affairs Manager (Biotech)

Location: Hybrid work from home with a few days per month in the Cambridge, Uxbridge, or Lisbon office; role available between Portugal and the United Kingdom

Salary in Portugal: EUR 48,957–66,237 gross per year

Company

hirify.global is a biotechnology company focused on researching, manufacturing, and delivering medicinal products to patients worldwide.

What you will do

• Ensure the acquisition and maintenance of EU licenses for clinical trials and marketed medicinal products.
• Plan and manage clinical trial, marketing application, and other regulatory submissions in line with global filing plans and EU requirements.
• Implement product-related regulatory strategies, processes, and activity plans for products in development and post-marketing phases.
• Provide guidance on scientific advice, orphan drug applications, paediatric plans, marketing authorisation mechanisms, and other regional procedures.
• Support EU label negotiations and contribute to regulatory product strategies.
• Research regulatory legislation, guidance, agency expectations, risks, and competitor labelling.

Requirements

• Degree and previous experience in a similar regulatory affairs role.
• Hands-on experience with EU registration procedures, including clinical trials, pre-marketing authorisation activities, marketing authorisation, post-approval changes, extensions, and renewals.
• Experience developing regulatory strategies for products in clinical development and post-marketing phases.
• Knowledge of EU legislation and regulations relating to medicinal products, including policies, procedures, and SOPs.
• Strong oral and written communication skills, with the ability to anticipate issues, resolve conflicts, and develop effective courses of action.
• Basic proficiency in using AI tools for day-to-day work.

Culture & Benefits

• Opportunities for professional growth and mobility across the global organization.
• Diverse and inclusive community where employees are empowered to contribute ideas and act.
• Total Rewards Plan covering health, finance and wealth, work-life balance, and career benefits.
• Flexible home-working arrangement with limited monthly office attendance.