Regulatory Affairs VP (Pharmaceuticals)

TL;DR

Regulatory Affairs VP (Pharmaceuticals): Leading regulatory activities in US and European markets with an accent on strategy development and compliance with FDA and EMA. Focus on securing approvals for innovative medicines in metabolic disease areas and managing cross-regional teams.

Location: Must be based in Europe or the United States

Company

hirify.global is a pharmaceutical company specializing in the development of innovative medicines for metabolic diseases.

What you will do

• Develop and execute regulatory strategies for U.S. and EU markets across the full product lifecycle.
• Lead interactions and negotiations with the FDA, EMA, and other key health authorities.
• Manage and develop a regional regulatory affairs team, including talent development and performance evaluation.
• Oversee regulatory budgets and optimize operational processes and knowledge databases.
• Collaborate with R&D, clinical, commercial, and quality teams to provide market access insights.
• Monitor global regulatory policy changes and assess their impact on commercialization plans.

Requirements

• Advanced degree (Master's or PhD) in Pharmacy, Medicine, Biology, Chemistry, or related fields.
• Minimum 15 years of experience in regulatory affairs, with at least 10 years engaging directly with FDA/EMA.
• Proven senior leadership experience in multinational pharma/biotech with successful IND/NDA/BLA or MAA approvals.
• Deep expertise in regulatory pathways for metabolic diseases (e.g., diabetes, obesity).
• English: C1+ (Fluency in written and spoken English is required).
• Location: Must be based in Europe or the United States.

Nice to have

• Professional certifications in regulatory affairs (e.g., RAC).
• Proficiency in Mandarin.

Culture & Benefits

• Flexible work arrangement: choose between hybrid (on-site and remote) or fully remote based on preference and business needs.
• Opportunity to lead global expansion in a high-impact medical field.
• Leadership role in a complex, matrixed international organization.