Lead Regulatory Affairs Strategist
11 hours ago
Genmab is an innovative biotechnology company dedicated to transforming the lives of patients through groundbreaking antibody therapies. With a strong focus on translational research and data sciences, we've established a robust pipeline of next-generation antibody technologies.
The RoleWe're seeking a seasoned Senior Director, Regulatory Affairs Strategy-EU/RoW to join our Global Regulatory Affairs organization. As a key member of our team, you'll be responsible for developing and executing global regulatory strategies to advance our portfolio of development pipeline candidate drugs and marketed products.
In this role, you'll work closely with cross-functional teams to provide strategic input and ensure operational execution of global submission activities. You'll also serve as the primary contact for assigned programs with EMA and oversee regulatory CROs for territories outside Japan and the US.
Your expertise will be essential in leading and mentoring a group of dedicated Regulatory Strategists with EU/ROW responsibilities for Genmab's assets across all stages of development.
This position is based in our Copenhagen Headquarters Office, Denmark, with onsite presence expected 60% of the time.
Key Responsibilities- Managerial/supervisory responsibilities
- Actively mentor the regulatory strategists with EU/ROW responsibilities
- Develop global regulatory strategies for assigned projects through integration of regional regulatory strategies and alignment with global development and commercial goals
- Lead or be responsible for planning and implementing regional regulatory procedures (e.g., clinical trial applications, marketing applications, label extensions, CMC changes, PIPs)
- Represent Regulatory Affairs across Genmab committees as indicated
- Evaluate and communicate to senior management regulatory risks and challenges, and mitigation options in a timely manner
- 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
- Evaluate regulatory mechanisms that allow optimization of product development (e.g., orphan drug designation, PRIME designation, compassionate use, pediatric plans) and ensure they are implemented, if applicable
- A minimum of Bachelor's degree or equivalent in scientific discipline or health-related field; PhD or MD degree preferred
- Minimum of 10 years of experience in Regulatory Affairs, across all development phases
- 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 preferred
- Prior experience leading health authority meetings with the EMA or other health authorities
- Experience with submitting and bringing MAAs to completion in Europe/ROW
- Experience with variation procedures
- 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)
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