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Senior Director, Regulatory Affairs Strategy-EU/RoW
4 weeks ago
The Role
As a Senior Director, Regulatory Affairs Strategy-EU/RoW, you will assume responsibility for the EU/ROW regulatory strategy for an assigned program and will manage a group of Regulatory Strategists with EU/ROW responsibilities for our programs across all stages of development. The chosen candidate may act as the deputy for the Head of Regulatory Affairs on Labeling Review Committees, Protocol Review Committees, and Audit/Inspection Committees. The ultimate goal is to ensure an optimal development and implementation of an EU/ROW regulatory strategy for Genmab's programs that enables an integrated global clinical development and commercial strategy. This position will report to the Head of Regulatory Affairs.
Key Responsibilities
- Managerial/supervisory responsibilities.
- Actively mentoring of the regulatory strategists with EU/ROW responsibilities.
- Develop global regulatory strategies for the assigned projects through integration of regional regulatory strategies and in line with the global development and commercial goals.
- Lead or be responsible for the planning and implementation of regional regulatory procedures (e.g., clinical trial applications, marketing applications, label extensions, CMC changes, PIPs).
- Represent Regulatory Affairs across Genmab committees as indicated.
- Proactively and in a timely manner, evaluate and communicate to senior management regulatory risks and challenges, and mitigation options.
- Follow all correspondence with the competent authorities across programs from EU/ROW.
- Oversee CRO quality, accountabilities and deliverables related to Regulatory activities.
- Assess EU and MHRA regulatory guidelines and regulations and current regulatory environment/landscape and their impact on the development of Genmab products.
- Interact with health authorities and lead/participate in health authority meetings.
- Present the regulatory strategy/position to senior management and health authorities, as appropriate. Interpret the communication of any health agency feedback and assess the impact on programs.
- Evaluate regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, PRIME designation, compassionate use, pediatric plans) and ensure that they are implemented, if applicable.
- Ensure compliance with all internal and external requirements and procedures related to Regulatory Affairs.
- Participate in regulatory SOP development.
- Provide input into streamlining internal RA processes.
Requirements
- A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field. PhD or MD degree will be preferred.
- Minimum of 10 years of experience in Regulatory Affairs, across all development phase
- Significant experience in proactively planning and implementing highly complex clinical submission strategies
- Experience in leading a team of regulatory strategist professionals.
- Expertise in drug development and EU regulatory mechanisms to expedite development.
- Experience within oncology is preferred.
- Prior experience leading health authority meetings with the EMA or other health authorities
- Experience with submitting and bring to completion MAAs in Europe/ROW
- Experience with variation procedures
- Strong project management skills
Moreover, you meet the following personal requirements:
- Strong organizational, communication, and time management skills needed to run multiple ongoing projects simultaneously
- Must have attention to detail and able to problem solve
- Be able to work independently with an ability to drive projects to successful outcomes
- Robust cross-functional collaboration 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 determined 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 Genmab
- Genmab is a biotechnology company that leverages the effectiveness of an agile working environment 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.
- We thrive on connecting with each other to innovate.
