Senior Director, Regulatory Affairs Strategy Leader
1 month ago
We are seeking an experienced and passionate leader to join our Global Regulatory Affairs organization at Genmab A/S. As a Senior Director, Regulatory Affairs Strategy Leader, you will be responsible for developing global strategies to advance our portfolio of development pipeline candidate drugs and marketed products.
You will provide strategic input and ensure operational execution of global submission activities. Your expertise in drug development and EU regulatory mechanisms will enable you to expedite the development process.
In this role, you will interface directly with health authorities such as the EMA as the primary contact for assigned programs and have oversight of regulatory CROs for territories outside of Japan and the US. You will also lead and mentor a team of dedicated Regulatory Strategists with EU/Rest of World (ROW) responsibilities for our assets across all stages of development.
This position is based in our Copenhagen Headquarters Office, Denmark, with onsite presence 60% of the time.
Key Responsibilities:
- Develop global regulatory strategies for assigned projects through integration of regional regulatory strategies and in line with global development and commercial goals.
- Lead or be responsible for planning and implementing regional regulatory procedures, including clinical trial applications, marketing applications, label extensions, CMC changes, and PIPs.
- Represent Regulatory Affairs across Genmab committees as indicated.
- Evaluate and communicate regulatory risks and challenges to senior management, providing mitigation options.
- Follow correspondence with 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, evaluating their impact on the development of our products.
- Interact with health authorities and lead/participate in health authority meetings.
- Present regulatory strategies/positions to senior management and health authorities, as appropriate.
- Evaluate regulatory mechanisms that allow optimization of product development, ensuring they are implemented if applicable.
- Ensure compliance with internal and external requirements and procedures related to Regulatory Affairs.
- Participate in regulatory SOP development.
Requirements:
- A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field; PhD or MD preferred.
- Minimum of 10 years of experience in Regulatory Affairs, across all development phases.
- Significant experience in proactively planning and implementing complex clinical submission strategies.
- Experience 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 submitting and bringing MAAs in Europe/ROW to completion.
- Experience with variation procedures.
- Strong project management skills.
About Us:
Genmab A/S is an international biotechnology company committed to improving lives through innovative antibody therapeutics. Our team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates.
We have formed strategic partnerships with biotechnology and pharmaceutical companies to help develop and deliver novel antibody therapies to patients. By 2030, our vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines.
We are committed to fostering workplace diversity and believe it is essential for our continued success. We welcome applicants from diverse backgrounds and encourage them to apply.
Genmab A/S is headquartered in Copenhagen, Denmark, with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S., and Tokyo, Japan.
Salary:
The estimated salary for this position is between $180,000 and $250,000 per year, depending on experience.
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