EU Regulatory Affairs Manager (Biosimilars)

Location: Based in Portugal or the United Kingdom, with flexibility to work from home and a few days per month in the Cambridge, Uxbridge, or Lisbon office.

Salary: EUR 48,957–66,237 gross annually for candidates based in Portugal. UK compensation is aligned with the local market.

Company

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

What you will do

• Develop and execute European regulatory strategies for the biosimilar portfolio from development and registration through launch and lifecycle management.
• Plan and manage EU/EEA submissions, including MAAs, Health Authority responses, CTAs/CTIS activities, and post-approval lifecycle submissions.
• Collaborate with global and regional teams across CMC, Clinical, Safety, Quality, Legal, and Commercial functions.
• Lead Health Authority interactions by preparing briefing materials, regulatory responses, and follow-up actions.
• Support SmPC, Package Leaflet, artwork, and regional labelling negotiations.
• Monitor EU biosimilar legislation, guidance, regulatory policy, and competitor intelligence while improving regulatory processes and documentation.

Requirements

• Degree education.
• Knowledge of biosimilar drug development in a regional regulatory environment, including direct experience with EU biosimilar submissions and post-approval maintenance.
• Experience working with policies, procedures, and SOPs.
• Awareness of regional procedures for clinical trials, marketing authorisation, post-approval changes, extensions, and renewals.
• Experience with the EU Centralised Procedure and understanding of EU regulatory incentives.
• Strong written and oral communication, issue prevention and resolution skills, and experience collaborating across multiple regions in a global or matrixed organisation.

Culture & Benefits

• Growth opportunities across the global organisation.
• Diverse and inclusive community that encourages employees to contribute ideas and take action.
• Total Rewards Plan covering health, finance and wealth, work-life balance, and career benefits.
• Hybrid flexibility with home working and periodic office attendance.