EU Regulatory Affairs Manager (Biotech)

Location: Hybrid role based between Portugal and the United Kingdom, with flexibility to work from home and a few days per month from the Cambridge or Uxbridge offices

Company

hirify.global is a global biotechnology company researching, manufacturing, and delivering medicines to patients worldwide.

What you will do

• Ensure required EU licenses are acquired and maintained for clinical-trial and marketed medicinal products.
• Plan and manage clinical-trial, marketing-authorisation, and other regulatory submissions in line with global filing plans and EU requirements.
• Develop and execute EU regulatory strategies for products in clinical development and post-marketing phases.
• Provide guidance on scientific advice, orphan-drug applications, paediatric plans, expedited development, and marketing-authorisation mechanisms.
• Support EU label negotiations and provide content guidance for regulatory documents and agency meetings.
• Research regulatory legislation, guidance, precedents, competitor labelling, and potential agency risks.

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 clinical-development and post-marketing products.
• Knowledge of EU legislation and regulations for medicinal products, as well as policies, procedures, and SOPs.
• Strong written and verbal communication, issue anticipation, conflict resolution, and course-of-action development skills.
• Basic proficiency with AI tools for day-to-day work.

Culture & Benefits

• Opportunities for professional growth and career mobility across the global organization.
• Diverse and inclusive workplace where employees are empowered to contribute ideas and take action.
• Total Rewards Plan covering health, financial, work-life balance, and career benefits.
• Hybrid work arrangement with home working and periodic office attendance.