Global Regulatory Strategy Lead for Life Sciences

ProductLife Group; Amsterdam; On-site; EUR 70,000 - 90,000; Full time

Job summary

A global provider of outsourcing and consulting services is seeking a Regulatory Affairs Strategy Specialist to lead regulatory strategies for client projects. The ideal candidate will have over 5 years of experience in regulatory affairs, a relevant PhD or MSc, and strong knowledge of pharmaceutical legislation. Responsibilities include managing regulatory procedures, conducting gap analyses, and mentoring staff. This role emphasizes leadership in a fast-paced environment, requiring excellent communication and strategic thinking skills.

Qualifications

• Minimum 5 years in regulatory affairs or related strategic roles.
• Proven experience working with EMA, NCAs, and preferably the US FDA.
• Experience across multiple disciplines and international regulatory environments.
• Experience working with large molecules.
• Strong background in pre-marketing activities.
• Demonstrated ability to independently manage the role.
• Scientific writing experience is a plus.

Responsibilities

• Lead the overall regulatory strategy and execution for assigned projects.
• Define global regulatory strategies, including RSPs, Target Product Profiles, and roadmaps.
• Conduct gap analyses and due diligence for regulatory compliance.
• Manage regulatory procedures and oversee the preparation of submissions.
• Lead project teams and health authority interactions.
• Mentor and train staff on RAS activities.

Skills

In-depth knowledge of pharmaceutical legislation and best practices

Excellent communication and presentation skills in English

Strong writing, analytical, and problem-solving abilities

Strategic thinking and decision-making capabilities

Project management and multitasking proficiency

Diplomatic and flexible approach to stakeholder management

Ability to perform under pressure with limited resources

Education

PhD or MSc in Pharmacy, Medical Biology, Chemistry, or Life Science

Job description

A global provider of outsourcing and consulting services is seeking a Regulatory Affairs Strategy Specialist to lead regulatory strategies for client projects. The ideal candidate will have over 5 years of experience in regulatory affairs, a relevant PhD or MSc, and strong knowledge of pharmaceutical legislation. Responsibilities include managing regulatory procedures, conducting gap analyses, and mentoring staff. This role emphasizes leadership in a fast-paced environment, requiring excellent communication and strategic thinking skills.