Global Regulatory Strategy Lead — Rare Diseases

Pharming Group; Leiden; On-site; EUR 90,000 - 130,000; Full time

Job summary

Pharming Group in Leiden is seeking a Manager, Global Regulatory Affairs Strategy to shape and implement regulatory strategies for products in development and on the market. You will lead cross-functional teams, guide submissions to Health Authorities, and ensure regulatory compliance across global markets.

The role requires at least five years in Global Regulatory Affairs, with preference for rare disease experience.

Qualifications

• Bachelors degree in a life sciences or technical field from an accredited university; RAC certification preferred.
• A minimum of five (5) years related experience in Global Regulatory Affairs.
• Rare disease or specialty pharmaceutical experience preferred.

Responsibilities

• Develop global regulatory strategies for products in development and marketed stages.
• Develop regulatory content and timelines aligned to strategic goals including key milestones.
• Interface with Health Authorities as regulatory representative on cross-functional teams.
• Identify regulatory risks and assist in mitigation.
• Contribute to regulatory submissions (INDs, CTAs, filings, amendments).
• Coordinate with Regulatory Operations for timely submissions; ensure alignment with requirements.

Skills

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Excellent communication

Regulatory risk assessment

Education

Bachelor's degree in life sciences or technical field

RAC certification

Job description

Pharming Group in Leiden is seeking a Manager, Global Regulatory Affairs Strategy to shape and implement regulatory strategies for products in development and on the market. You will lead cross-functional teams, guide submissions to Health Authorities, and ensure regulatory compliance across global markets.

The role requires at least five years in Global Regulatory Affairs, with preference for rare disease experience.