Global Regulatory Operations Lead, Process & Compliance

Genmab; 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, an international biotechnology company based in Copenhagen, Denmark, seeks a Senior Manager, Global Regulatory Operations, Process & Compliance. You will shape SOPs/WIs, support regulatory audits and inspections, and oversee GxP vendors and Health Authority portal access to streamline marketing authorization activities.

In this senior individual contributor role, you will report to the Associate Director and contribute to cross-functional regulatory operations, ensuring robust compliance

Qualifications

• 8+ years of Regulatory Affairs experience in the pharmaceutical industry, including EU/US/RoW exposure.
• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Medicine or related discipline.
• Experience with Regulatory Affairs activities across drug development and lifecycle management.
• Excellent written and verbal communication in English.
• Knowledge of laws, regulations and industry guidance relevant to the pharmaceutical industry.
• Strong organizational and prioritization skills with ability to manage multiple activities.

Responsibilities

• Develop and maintain GRA SOPs and WIs.
• Coordinate GRA review of SOPs owned by other functional areas.
• Maintain GRA setup and oversight of GxP vendors and subcontractors.
• Oversee Health Authority portal and database access for regulatory activities.
• Optimize processes and tools for oversight activities.
• Coordinate GRA participation in regulatory audits and inspections.
• Manage GRA compliance activities including QE processes and XEVMPD reporting.
• Act as Training SME for GRA.

Skills

Regulatory affairs

Regulatory compliance

SOPs & WIs

Audit & inspections

English communication

Project management

Leadership & negotiation

Education

Bachelor’s or Master in Life Sciences/Pharmacy/Medicine

Job description

Genmab, an international biotechnology company based in Copenhagen, Denmark, seeks a Senior Manager, Global Regulatory Operations, Process & Compliance. You will shape SOPs/WIs, support regulatory audits and inspections, and oversee GxP vendors and Health Authority portal access to streamline marketing authorization activities.

In this senior individual contributor role, you will report to the Associate Director and contribute to cross-functional regulatory operations, ensuring robust compliance