Associate Director, Regulatory Affairs

Location: SANT FELIU DE LLOBREGAT, Spain

Company

hirify.global is a pharmaceutical company specializing in medical dermatology, dedicated to transforming patients' lives by addressing unmet needs.

What you will do

• Define and implement global regulatory strategies for both development and marketed products.
• Lead the preparation and submission of regulatory dossiers, including CTA, MAA, variations, and renewals.
• Provide strategic regulatory guidance to cross-functional teams (Clinical, CMC, Safety, and Market Access).
• Manage interactions with health authorities and coordinate responses to regulatory queries.
• Monitor regulatory changes to assess impact on the product portfolio and operations.
• Support due diligence and licensing activities from a regulatory perspective.

Requirements

• Bachelor’s degree in Life Sciences or Pharmacy (advanced degree preferred).
• Minimum 8 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Proven track record in global regulatory submissions and health authority interactions.
• Fluent in English.

Nice to have

• Strong knowledge of EU, US, and international regulatory frameworks.
• Excellent project management and organizational skills.
• Ability to work effectively in cross-functional and multicultural environments.

Culture & Benefits

• Recognized as a Top Employer in Spain (since 2008) and Germany (since 2025).
• Culture that encourages independent thinking, ownership, and impactful work.
• Commitment to employee growth and professional development.
• Environment focused on innovation and care for patient needs.