• This position is responsible for the development and management of Standard Operating Procedures and related training resources for the Global Regulatory Affairs organization.  Additionally, the position is responsible as the Regulatory Point of Contact for any planned and unplanned health authority inspections and internal audits. Provides audit expertise to the Global Regulatory Affairs organization through project management and oversight of findings and necessary mitigations.

This role is based out of our HQ in Copenhagen, Denmark and is hybrid, which means you will work 60% from site.

Responsibilities

• Lead the Regulatory Affairs Process Expert Group (PEG) and be the functional area representative on the Clinical PEG and any other PEGs.
• Development & maintenance of Global Regulatory Affairs Standard Operating Procedures (SOPs) and Work Instructions (WI)
• Responsible for regulatory audit and inspection readiness activities to prepare teams for audits/inspections; work with applicable internal functions and external agencies to resolve any Regulatory-related issues identified
• Ensure development of training and other resources to support Genmab’s Regulatory Framework
• Drive training completion compliance across the Global Regulatory Affairs organization

Minimum qualifications

• 6-8 years of experience required in EU, RoW and/or US regulatory compliance or similar function at pharmaceutical companies.
• Experience with GCP and regulatory affairs functional area activities within a pharmaceutical company.
• Experience with JP inspections would be a plus but not required.
• Preferred experience hosting and/or leading regulatory inspections, audits and/or continuous improvement projects.
• Demonstrated ability to effectively manage multiple tasks applying organization and prioritization skills, driven to meet timelines, and results oriented.

Other Job Specific Skills

• Excellent interpersonal communication (written and oral), teamwork, leadership, organizational and negotiating skills.
• Familiar with project management and formal continuous process improvement techniques.
• Knowledge of and experience with laws, regulations and industry guidance that affect the pharmaceutical industry.

About You

• You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
• You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
• You are a generous collaborator who can work in teams with diverse backgrounds
• You are determined to do and be your best and take pride in enabling the best work of others on the team
• You are not afraid to grapple with the unknown and be innovative
• You have experience working in a fast-growing, dynamic company (or a strong desire to)
• You work hard and are not afraid to have a little fun while you do so

Locations

Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.

About Genmab

Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.