Regulatory Affairs Development Lead—Strategy & Growth

PharmaRelations AB; Stockholms kommun; On-site; SEK 1,800,000 - 3,200,000; Full time

Job summary

PharmaRelations AB, based in Sweden, seeks a Head of Regulatory Affairs Development to lead and expand Regulatory Affairs services for biotech and pharmaceutical clients from development through regulatory approval. The role blends leadership, strategic advisory work and business development across the Nordic region.

You will guide the Regulatory Affairs Development team, engage with health authorities, and drive growth while working from the Solna office with occasional Nordic travel.

Qualifications

• Extensive Regulatory Affairs experience in clinical stage development
• Experience developing global regulatory strategies for drug development
• Strong knowledge of EU and US regulatory frameworks
• Experience leading teams of regulatory professionals
• Experience with health authority interactions (FDA/EMA)
• Experience with CTA/IND submissions
• Experience from biotech/pharma/regulatory consultancy environments

Responsibilities

• Lead and develop the Regulatory Affairs Development team
• Coach and develop regulatory affairs consultants
• Drive business development and build client relationships
• Identify new consulting opportunities in the market
• Act as trusted strategic advisor to biotech and pharmaceutical clients
• Develop and execute global regulatory strategies for clients
• Provide regulatory leadership across drug development programs
• Support interactions with health authorities including FDA and EMA
• Shape and expand PharmaRelations' Regulatory Affairs Development offerings

Skills

Regulatory strategy

Global regulatory

Leadership

Communication

EU/US frameworks

Health authority interactions

Client advisory

Education

Life Sciences degree

Job description

PharmaRelations AB, based in Sweden, seeks a Head of Regulatory Affairs Development to lead and expand Regulatory Affairs services for biotech and pharmaceutical clients from development through regulatory approval. The role blends leadership, strategic advisory work and business development across the Nordic region.

You will guide the Regulatory Affairs Development team, engage with health authorities, and drive growth while working from the Solna office with occasional Nordic travel.