EU Regulatory Affairs Manager (Pharmaceuticals)

Location: Lisbon, Portugal

Salary: EUR 48,957.45–66,236.55 per year

Company

hirify.global is a global healthcare company developing medicines and supporting patients through innovation, science, and technology.

What you will do

• Manage EU regulatory submissions for clinical trials, marketing applications, post-approval changes, extensions, and renewals.
• Support regulatory strategies for medicinal products in clinical development and post-marketing phases.
• Provide guidance on EU regulatory mechanisms, including scientific advice, orphan applications, paediatric plans, and marketing authorisation procedures.
• Support EU label negotiations and provide content guidance for regional regulatory documents and meetings.
• Research EU legislation, regulatory guidance, agency precedents, competitor labelling, and potential regulatory risks.
• Depending on business needs and experience, lead EU regulatory activities for one or more products.

Requirements

• Degree and previous experience in a similar regulatory affairs role.
• Hands-on experience with EU registration procedures for 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 for medicinal products, as well as policies, procedures, and SOPs.
• Strong written and oral communication skills, with the ability to anticipate issues, resolve conflicts, and develop effective courses of action.
• Basic proficiency in using AI tools to support day-to-day work.

Culture & Benefits

• Flexible work arrangements.
• Opportunities to learn, develop, and move across the global organization.
• Diverse and inclusive workplace with opportunities to contribute ideas and take initiative.
• hirify.global Total Rewards Plan covering healthcare, finance, wealth, and career benefits.