Global Regulatory Strategy Manager

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

Job summary

Pharming Group n.V. seeks an experienced Manager, GRA Strategy to shape and execute global regulatory strategies for products in development and marketed.

You will manage filings and submissions across development stages and post-approval, providing strategic oversight to ensure alignment with Health Authority requirements. The role requires strong communication, planning, and regulatory expertise, with experience in rare diseases or specialty pharma preferred.

Qualifications

• Bachelor's degree in a life sciences or technical field; advanced degree preferred.
• RAC certification preferred.

Responsibilities

• Develops global regulatory strategies for Pharming products in development and in market.
• Manages regulatory filings and submissions across all development stages and post-approval.
• Provides strategic regulatory oversight ensuring Health Authority requirements are met.
• Interacts with Health Authorities and cross-functional teams to guide regulatory strategy.
• Identifies regulatory risks and mitigations; monitors regulatory information for stakeholders.
• Contributes to submissions (INDs, CTAs, regulatory docs, filings, amendments).
• Coordinates with Regulatory Operations for timely submissions; applies regulatory knowledge to projects.

Skills

Oral and written communication

Planning skills

Attention to detail

Self-motivated

Adaptability

Education

Bachelors degree in life sciences or technical field

RAC certification preferred

Job description

Pharming Group n.V. seeks an experienced Manager, GRA Strategy to shape and execute global regulatory strategies for products in development and marketed.

You will manage filings and submissions across development stages and post-approval, providing strategic oversight to ensure alignment with Health Authority requirements. The role requires strong communication, planning, and regulatory expertise, with experience in rare diseases or specialty pharma preferred.