Senior Manager, Global Regulatory Operations, 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

At Genmab, we are dedicated to building extra[not]ordinary® futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines® that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.

Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.

Does this inspire you and feel like a fit? Then we would love to have you join us!

The Role

Genmab is expanding into new markets, bringing increased activity and complexity across Global Regulatory Affairs (GRA). We have built a solid foundation within our Process & Compliance area, and we are now looking for a Senior Manager, Global Regulatory Operations, Process & Compliance to help us take the next step.

In this role, you will have the opportunity to influence both what we do and how we do it. You will help establish and maintain Standard Operating Procedures (SOPs) and Work Instructions (WIs), support GRA’s involvement in audits and inspections, and maintain oversight of GxP vendors and subcontractors.

You will also oversee Health Authority portal and database access supporting marketing authorization activities, while helping to optimize the related processes and tools. In addition, you will support a range of compliance activities across GRA. This is a senior individual contributor role, at Senior Manager level, reporting to the Associate Director, Global Regulatory Operations, Process & Compliance Lead.

Responsibilities

• Develop and maintain GRA Standard Operating Procedures (SOPs) and Work Instructions (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.

Requirements

• Minimum of 8 years of experience in Regulatory Affairs within the pharmaceutical industry, including 3 - 5 years in a comparable Regulatory Compliance role across the EU, US and/or Rest of World (RoW).
• Bachelor’s or master’s degree in Life Sciences, Pharmacy, Medicine or a related discipline.
• Experience with Regulatory Affairs activities across drug development and/or life-cycle management within a pharmaceutical company.
• Knowledge of laws, regulations and industry guidance relevant to the pharmaceutical industry.
• Strong organizational and prioritization skills, with the ability to manage multiple activities and deliver against timelines.
• Excellent written and verbal communication skills in English.
• Strong interpersonal, teamwork, leadership and negotiation skills.
• Familiarity with project management and continuous process improvement techniques.
• Experience with GCP is considered an advantage. Experience coordinating regulatory inspections, audits and/or continuous improvement projects is also considered an advantage.
• Based in Denmark, with the ability to work 60% on‑site at our Copenhagen headquarters.

The proposed gross annual/hourly base salary range for this position, in the primary location, based on a full time schedule is:

DKK636.480,00---954.720,00

The final salary offer will depend on several factors, including your skills, qualifications, and experience.

In addition to base salary, this position is eligible for additional forms of compensation, such as discretionary bonuses and long‑term incentives.

Benefits

When you join Genmab, you become a part of a culture that supports your physical, financial, social, and emotional well‑being. Our benefits include, but are not limited to:

• Pension
• Health insurance and wellness benefits
• Paid time off
• Employee support programs

Further details on eligibility for compensation and benefits based on the role will be provided during the recruitment process.

About Genmab

Genmab is an international biotechnology company with a core purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard‑working, innovative and collaborative team has invented next‑generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T‑cell engagers, antibody‑drug conjugates, next‑generation immune checkpoint modulators and effector function‑enhanced antibodies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock‑Your‑Socks‑Off (KYSO®) antibody medicines.

Established in 1999, Genmab is headquartered in Copenhagen, Denmark with international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.

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