Associate Director/Senior Manager, Global Regulatory Affairs Project Lead

The Role

As a Senior Manager/Associate Director, Global Regulatory Affairs Project Lead you will be a part of our Global Regulatory Affairs organization.

In this role, you 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 chosen candidate may also be allocated as EU/ROW regulatory strategy lead to one or multiple compounds in early 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. This position will report to the Global Regulatory Strategy Team Lead.

Key responsibilities include

• 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 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 5 years of experience in Regulatory Affairs, preferably in development phase

• Experience in proactively planning and executing highly complex clinical submission strategies

• A good understanding of drug development and EU regulatory procedures. Experience within oncology will be a plus

• Prior experience leading health authority meetings with the EMA or other health authorities. Experience with PIPs will be a plus

• Strong project management skills

Moreover, you meet the following personal requirements:

• Strong organizational, communication, and time management skills needed to manage 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 self-driven 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

This role is located in Copenhagen, Denmark and is hybrid.

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.