Strategic EU/ROW Regulatory Affairs Director
7 days ago
About the Role
\Genmab, a leading biotechnology company, is seeking an experienced Senior Director to lead its Global Regulatory Affairs organization. Located in Copenhagen, Denmark, this role offers a unique opportunity to shape the company's regulatory strategy and drive innovation in cancer treatment.
\The successful candidate will be responsible for developing and executing global strategies to advance Genmab's portfolio of development pipeline candidate drugs and marketed products. This includes providing strategic input, ensuring operational execution of global submission activities, and interfacing directly with health authorities such as the EMA.
\This position requires a minimum of 10 years of experience in Regulatory Affairs, across all development phases, with significant expertise in drug development and EU regulatory mechanisms. The ideal candidate will have a strong track record of leading teams, mentoring, and collaborating with cross-functional groups to achieve shared goals.
\In addition to technical expertise, the successful candidate will possess excellent communication, time management, and problem-solving skills. They will be able to work independently, prioritize tasks in a fast-paced environment, and maintain a focus on delivering high-quality results.
\Key Responsibilities:
\- \
- Develop and execute global regulatory strategies for assigned projects\
- Lead or be responsible for planning and implementing regional regulatory procedures\
- Represent Regulatory Affairs across Genmab committees\
- Evaluate and communicate regulatory risks and challenges to senior management\
- Oversight of CRO quality, accountabilities, and deliverables related to Regulatory activities\
- Assess EU and MHRA regulatory guidelines and regulations and current regulatory environment/landscape\\-
- Interact with health authorities and lead/participate in health authority meetings\
- Presentation of regulatory strategy/position to senior management and health authorities\\-
- Ensure compliance with internal and external requirements and procedures related to Regulatory Affairs\
- Participate in regulatory SOP development\\-
- Provide input into streamlining internal RA processes\\-
- Experience working in a dynamic company, preferably in oncology\\-
- Prior experience leading health authority meetings with the EMA or other health authorities\\-
- Experience with submitting and bringing to completion MAAs in Europe/ROW\\-
- Experience with variation procedures\\-
- Strong project management skills\\-
- Able to work independently and drive projects to successful outcomes\\-
- Foster collaborative relationships to achieve shared goals\\-
- Prioritize work in a fast-paced environment\\-
- Maintain a focus on delivering high-quality results\\-
- Possess excellent communication, time management, and problem-solving skills\\-
- Demonstrate a commitment to contributing to the overall success of Genmab\\-
- Hold a Bachelor's degree or equivalent in a scientific discipline or health-related field, PhD or MD degree preferred\\-
- Salary range: 120,000 - 180,000 USD annually, dependent on qualifications and experience\\-
- Estimated salary based on location and job responsibilities\\-
- Benefits package including comprehensive health insurance, retirement plan, and paid time off\\-
- Opportunity to work in a collaborative, innovative environment\\-
- Genmab is an equal opportunities employer, committed to diversity and inclusion\\-
- Please note that if you are applying for a position in the Netherlands, Genmab's policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year\\-
- Additional location: Utrecht, Netherlands
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