Associate Director, Regulatory Affairs (Pharmaceutical)

Location: Porto Salvo, Portugal

Company

hirify.global provides clinical research services, commercial insights, and healthcare intelligence for life sciences and healthcare organizations.

What you will do

• Lead multiple global regulatory projects as Project Lead or Regulatory Lead, managing delivery quality, timelines, budgets, resources, and client expectations.
• Develop regulatory strategies supporting global clinical development and product registration objectives.
• Prepare and coordinate submission documents, including IMPDs, IND meeting packages, Scientific Advice packages, iPSPs/PIPs, Orphan Drug Designation, Fast Track Designation, and Accelerated Approval materials.
• Partner with regulatory publishing and operations teams on compliant BLA, NDA, MAA, IND, CTA, and supplemental submissions.
• Provide strategic guidance to clients, project teams, and cross-functional stakeholders while serving as a contact for regulatory authorities.
• Assess regulatory risks, develop mitigation and contingency plans, and support FDA, EMA, MHRA, and national competent authority interactions.

Requirements

• Bachelor’s or Master’s degree in a life sciences discipline.
• Extensive regulatory affairs experience in pharmaceutical, biotechnology, CRO, or consulting environments.
• Demonstrated experience leading regulatory projects and client engagements.
• Strong understanding of clinical development, regulatory submission pathways, and IND or CTA submissions.
• Experience managing project budgets, resource planning, multiple priorities, and stakeholder relationships.
• Excellent written and verbal English communication skills required.

Nice to have

• Experience supporting IND submissions and working across EU and US regulatory environments.
• Experience with global regulatory development programs.
• Additional language capabilities.
• Familiarity with AI-enabled productivity tools and modern digital ways of working.

Culture & Benefits

• Client-facing work across global pharmaceutical and biotechnology programs.
• Collaboration with multidisciplinary teams in a consulting environment.
• Work focused on accelerating the development and commercialization of medical treatments.
• Inclusive culture emphasizing diversity, belonging, equality, and collaboration.