Associate Director, Regulatory Affairs

TL;DR

Associate Director, Regulatory Affairs (Pharmaceuticals): Leading regulatory strategies and operations to support the development, registration, and lifecycle management of pharmaceutical products with an accent on regulatory compliance and submission excellence. Focus on managing health authority interactions, implementing global regulatory strategies, and ensuring compliance across global markets.

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.