- Lead the Global Regulatory Affairs (GRA) organization at Genmab by devising global and U.S. regulatory strategies to drive the development of the company's pipeline of candidate drugs.
- Directly engage with the U.S. FDA as the key liaison for the company for designated programs.
- Operate from our Princeton, NJ office, in adherence to our hybrid work policy, with onsite presence required 60% of the time.
- Function as the U.S./Global Regulatory Leader (GRL) for assigned projects, spearheading the development, implementation, and management of regulatory strategies in alignment with the Product Development Plan.
- Represent GRA in Compound Development Teams (CDT), Global Regulatory Teams (GRT), and Submission Teams, ensuring compliance with regulatory standards for programs and products.
- Evaluate regulatory risks and propose mitigation strategies to project teams and management.
- Drive the creation of briefing materials and readiness for health authority meetings.
- Participate in the creation and review of submission documents for INDs/CTAs and marketing applications.
- Collaborate with the Labeling team on developing Company Core Data Sheet and US Prescribing Information.
- Possess a BSc or MSc in life sciences (PharmD, PhD preferred).
- Bring 5-8 years of Regulatory Affairs experience in the industry, with a focus on Oncology and/or immunology and inflammation.
- Demonstrate prior experience in interacting/negotiating with regulatory authorities such as FDA and EMA.
- Exhibit strong strategic capabilities for decision-making and a solid understanding of global regulations and the U.S. pharmaceutical market.
- You are deeply passionate about our mission to enhance patient lives through innovative cancer treatments.
- You embody excellence in your work, embracing a scientific approach to problem-solving.
- You thrive in collaborative environments with diverse teams.
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Director, Regulatory Affairs Strategy - Princeton, United States - Genmab A/S
Description
At Genmab, we are dedicated to shaping remarkable futures together by developing groundbreaking antibody products and leading-edge therapies that revolutionize patient lives and the future of cancer treatment and other severe diseases. Our team is characterized by individuals who are empathetic, open, and results-oriented, and our company culture is marked by innovation and a solid foundation in science. We believe that embracing our uniqueness, striving for excellence, and staying true to ourselves are crucial in fulfilling our mission.
The PositionGenmab maximizes the benefits of an agile work setting to foster employee work-life balance. Our offices, be it collaborative spaces or remote work setups, encourage connection and innovation.
About GenmabGenmab is a global biotech company driven by a core purpose that inspires its dedicated team to advance patient care through innovative antibody therapeutics. With a focus on next-gen antibody technology platforms, the company aims to revolutionize cancer treatment and other serious diseases.
Our Commitment to Diversity, Equity, and InclusionGenmab is devoted to promoting workplace diversity at all organizational levels, recognizing it as a foundation for sustained success. We uphold a policy of non-discrimination based on various factors and encourage a diverse workforce.
