Global Regulatory Ops Leader — Process & Compliance

Genmab A/S; København; On-site; DKK 636,000 - 955,000; Full time

Benefits offered by this job

Pension

Health insurance and wellness benefits

Paid time off

Employee support programs

Job summary

Genmab is expanding into new markets and we are seeking a Senior Manager, Global Regulatory Operations, Process & Compliance to shape how we work. You will help establish SOPs and WIs, support GRA audits and inspections, and oversee GxP vendors and subcontractors.

This is a senior individual contributor role based in Denmark, reporting to the Associate Director. You will manage Health Authority portal and database access, optimize processes, and act as Training SME while ensuring compliance

Qualifications

• 8+ years in Regulatory Affairs within the pharmaceutical industry.
• 3–5 years in Regulatory Compliance across EU/US/ROW.
• Experience with audits, inspections, and QEs.

Responsibilities

• Develop and maintain SOPs and WIs.
• Represent GRA in process expert networks and coordinate GRA’s review of SOPs owned by other functional areas.
• Maintain GRA’s setup and oversight of GxP vendors and subcontractors.
• Maintain GRA’s setup and oversight of Health Authority portal and database access supporting marketing authorisation activities.
• Optimize processes and tools for our oversight activities.
• Coordinate GRA’s participation in regulatory audits and inspections, including preparation, participation and follow-up.
• Manage GRA compliance activities, including Functional Area Quality Events (QEs), QE process training and XEVMPD reporting.
• Act as the Training Subject Matter Expert (SME) for GRA.

Skills

Regulatory Affairs

Regulatory Compliance

Project management

Leadership

Education

Life Sciences degree

Job description

Genmab is expanding into new markets and we are seeking a Senior Manager, Global Regulatory Operations, Process & Compliance to shape how we work. You will help establish SOPs and WIs, support GRA audits and inspections, and oversee GxP vendors and subcontractors.

This is a senior individual contributor role based in Denmark, reporting to the Associate Director. You will manage Health Authority portal and database access, optimize processes, and act as Training SME while ensuring compliance