Sr. Director - Asset Regulatory Affairs Lead

July 18

Apply Now

Receive Emails with Similar Jobs

argenx

WebsiteLinkedInAll Job Openings

Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

1001 - 5000 employees

Founded 2008

🧬 Biotechnology

📋 Description

• Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. • argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets. • We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate. • argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases. • By translating immunology breakthroughs into innovative drug candidates, argenx is building a world-class portfolio of first-in-class antibodies.

🎯 Requirements

• Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on driving and implementing sound regulatory strategies leading to successful submissions and launches. • PhD or PharmD preferred. • Experience in the development of therapeutics for autoimmune neurology, renal or rheumatology conditions is preferred. • Prior experience working in rapidly growing pharmaceutical organizations is desirable. • A thorough understanding and experience with the development and licensure of biologic drugs for orphan and pediatric indications along with knowledge of and monitoring of the evolving landscape of regulations and guidelines. • Demonstrated ability to coordinate the development of critical regulatory documents involved in the development and approval of medicines with a focus on FDA, EMA, and PMDA. • A strong scientific background and ability to interact with scientists and clinicians. • 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. • Create a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities, optimizing their effectiveness to enable the timely and quality creation of local submissions. • 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. • You are a connector, building relationships and partnering across the organization to achieve the company goals. • You excel in a fast-paced, results-driven, highly accountable environment. • You are pragmatic, yet creative and innovative and lead while "rolling up your sleeves" to get it done. • You show strong leadership with proven ability to build, motivate and develop a team. • You resonate with the values of argenx and you are ready to drive the Company Culture. • You combine strategic thinking with the ability to execute, both individually and by leading teams, to achieve operational excellence in the face of challenging goal.