Director, Global Regulatory Affairs, Strategy

Director, Global Regulatory Affairs, Strategy

Genmab

Utrecht, Netherlands

The Role

Genmab is looking for a Director, EU/ROW Regulatory Lead to be a part of our Global Regulatory Affairs organization.

In this role, the candidate will represent RA in the Clinical Trial Teams and work closely with the CRO and internal stakeholders to ensure regulatory oversight and progress of the clinical trial submissions in EU/ROW. The candidate may also be allocated as EU/ROW Regulatory Strategy Lead to one or multiple compounds in early or late development and provide regulatory expertise and guidance on EU/ROW procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team to ensure an optimal EU/ROW regulatory strategy for the compound.

Responsibilities

The responsibilities of the role will include, but is not limited to:

• Represent RA in the Clinical Trial Teams and ensure oversight and progress of multiple, often highly complex, clinical trial submission activities;
• Represent EU/ROW in the Global Regulatory Team(s);
• Act as EU/ROW Regulatory Lead for the assigned project(s) and be responsible for the development and execution of the EU/ROW regulatory strategy;
• Lead the preparation of strategic regulatory documents, e.g. Briefing Packages, ODDs, PIPs, etc.;
• Plan, prepare and lead EMA or national Scientific Advice procedures, as relevant;
• Evaluate regulatory risks and recommend mitigation strategies to the cross-functional teams and management;
• Monitor and assess regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products;
• Maintain an updated knowledge of regulatory topics and regulations and participate in maintaining and preparing regulatory processes and ways of working.

Requirements

• A minimum of Bachelor’s degree or equivalent in scientific discipline or health-related field. Master’s degree preferred;
• Minimum of 8 years of experience in Regulatory Affairs, preferably in development phase up to and including submission of global marketing authorization applications;
• Experience in proactively planning and executing highly complex clinical submission strategies;
• Prior experience leading health authority meetings with the EMA or other health authorities;
• A good understanding of drug development and EU regulatory procedures;
• Experience within oncology and/or I&I will be a plus;
• Experience with PIPs will be a plus;
• Experience with development and regulatory requirements in ROW markets will be a plus;
• Strong project management skills.

Moreover, you meet the following personal requirements:

• Strong organizational, communication, and time management skills needed to lead multiple ongoing projects simultaneously;
• Must have attention to detail and be able to solve problems with minimal supervision;
• Be able to work independently with an ability to drive projects to successful outcomes;
• Robust cross-functional teamwork skills and enjoy working in a global environment;
• Skills in building and maintaining internal and external collaborative relationships to achieve shared goals;
• Highly motivated and dedicated individual who enjoys being challenged;
• Able to prioritize your work in a fast paced and changing environment;
• Goal-oriented and committed to contributing to the overall success of Genmab.

About You

• You are genuinely passionate about our purpose;
• You bring precision and excellence to all that you do;
• You believe in our rooted-in-science approach to problem-solving;
• You are a generous collaborator who can work in teams with a broad spectrum of backgrounds;
• You take pride in enabling the best work of others on the team;
• You can 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!