Senior Regulatory Affairs Expert
2 days ago
Unlock your potential in a dynamic environment at Genmab, a pioneering biotechnology company dedicated to transforming the lives of patients through innovative cancer treatments and therapies. As a Senior Regulatory Affairs Expert, you will play a pivotal role in shaping our regulatory strategies and ensuring seamless clinical trial submissions.
About the Role
The successful candidate will join our Global Regulatory Affairs organization, representing RA in Clinical Trial Teams and collaborating closely with CROs and internal stakeholders to ensure regulatory oversight and progress of clinical trial submissions in EU/ROW. You may also be allocated as EU/ROW regulatory strategy lead for one or multiple compounds in early development, providing regulatory expertise and guidance on procedural matters and documentation requirements to the Global Regulatory Team and Compound Development Team.
Key Responsibilities
- Represent RA in Clinical Trial Teams and ensure oversight and progress of multiple, often complex, clinical trial submission activities.
- Represent EU/ROW in the Global Regulatory Team(s).
- Act as EU/ROW regulatory lead for assigned projects, responsible for developing and executing EU/ROW strategies.
- Lead preparation of strategic regulatory documents, such as Briefing Packages, ODDs, PIPs, etc.
- Plan, prepare, and lead EMA or national Scientific Advice procedures as relevant.
- Evaluate regulatory risks and recommend mitigation strategies to cross-functional teams and management.
- Monitor and assess regulatory guidelines and regulations, and their impact on Genmab product development.
Requirements
- A minimum of Bachelor's degree or equivalent in a scientific discipline or health-related field; Master's degree preferred.
- Minimum of 8 years of experience in Regulatory Affairs, preferably in the development phase.
- Experience in proactively planning and executing complex clinical submission strategies.
- A good understanding of drug development and EU regulatory procedures; experience within oncology will be a plus.
- Prior experience leading health authority meetings with the EMA or other health authorities; experience with PIPs will be a plus.
- Strong project management skills.
Salary Estimate
We offer a competitive salary range of $120,000 - $160,000 per annum, depending on experience, location, and qualifications.
About Genmab
Genmab is an international biotechnology company committed to improving patient lives through innovative antibody therapeutics. With a passion for translational research and data sciences, we have developed next-generation antibody technology platforms and a proprietary pipeline of bispecific T-cell engagers, immune checkpoint modulators, effector function enhanced antibodies, and antibody-drug conjugates. Our team of experts collaborates globally to deliver novel antibody therapies to patients.
Why Join Us?
- Dedicated to fostering workplace diversity and inclusivity.
- Committed to protecting personal data and privacy.
- Hybrid work environment with flexible remote options.
- State-of-the-art laboratories and collaborative office spaces.
- Opportunities for growth and professional development.
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