Join argenx as a Global Regulatory Lead to support the rapid growth needed for successful commercialization. The role involves providing strategic, operational, and tactical regulatory insight on pre-approval and post-approval activities globally.
Requirements
- Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations
- At least 5-7 years of experience in global leadership roles with a focus on major regulatory regions such as FDA, EMA, or PMDA
- PhD or PharmD preferred
- Prior experience working in rapidly growing pharmaceutical organizations is desirable
- A thorough understanding of the drug development process with expertise in orphan drugs
- Knowledge of the developing landscape of regulations and guidelines, specifically in United States
- Demonstrated ability to coordinate the development of critical regulatory documents involved in the approval of medicines with a focus on the FDA
- Affinity with science and ability to interact with scientists and clinicians
- Experience interacting with regulatory authorities, especially the FDA and EMA
- Ability to speak and interact with a diverse group of individuals on technical and business topics
- Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally
- Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization
- A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills
- Track record of successful interactions with regulatory and health authorities
- Strong leadership with proven ability to build, motivate and develop a team
- Combines strategic thinking with the ability to execute, both individually and by leading teams (in a matrix environment) to achieve operational excellence in the face of challenging goals
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Visa Sponsorship
- Four Day Work Week
- Generous Parental Leave
- Tuition Reimbursement
- Relocation Assistance
