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.
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
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.
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