Regulatory Business Development Lead (Pharmaceuticals, Hybrid Europe)

Job summary

This role focuses on identifying and evaluating external innovation opportunities in the pharmaceutical sector, specifically within regulatory affairs. The position involves providing regulatory insights to support business development goals and ensuring effective use of internal expertise.

Qualifications

• Advanced degree in a scientific discipline (PharmD, PhD, MD, MSc).
• 10 years of global regulatory experience in the pharmaceutical or biotech industries.
• Proven track record in regulatory excellence within business development.
• Expertise in due diligence activities and regulatory risk assessment.
• In-depth knowledge of global regulatory systems and pathways.
• Experience working with external partners and Health Authorities.
• Strong strategic and operational mindset with problem-solving skills.

Responsibilities

Work setup

This position is based in Denmark but offers a hybrid work setup across Europe, allowing for collaboration with a global team.

• Provide regulatory input into portfolio and pipeline strategy.
• Lead regulatory due diligence activities for internal and external assets.
• Conduct global regulatory assessments covering various requirements.
• Identify regulatory risks and develop mitigation strategies.
• Drive structured due diligence processes to optimize resources.
• Deliver regulatory risk-benefit assessments and recommendations.
• Collaborate with Search & Evaluation and Business Development teams.
• Engage with external partners and Health Authorities.
• Contribute to best practices for regulatory involvement in business development.