Sr. Director Asset Regulatory Affairs Lead

argenx•Boston, MA

13d•Remote

About The Position

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, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases. 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 across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 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 in both early and late clinical-stages of development. Our employees are self-disciplined, hardworking, curious, trustworthy, humble, and truthful. They make choices according to what is best for the team, they live for opportunities to collaborate and make a difference, and they are the cornerstone of argenx. For the expansion of our regulatory team, argenx is looking for a Senior Director to support the rapid growth needed for its pipeline. Preferred locations: East Coast US Key Accountabilities and Responsibilities: The person in this role is a key member of the global regulatory leadership team and will be working on a late stage asset that is a pipeline in a product and preparing for its first global marketing application. The role provides a critical contribution to the development of product regulatory strategies for different indications and will be a key advisor and enabler of successful product launches and commercialization activities. This role serves as a close business partner and facilitator of regulatory activities across a portfolio of indications, and is expected to contribute to developing sound regulatory strategies globally. This role can be based remotely near Boston.

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.
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 ‎

Nice To Haves

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

Responsibilities

Regulatory Strategy for Asset Team Provide strategic, operational and tactical regulatory insight on global activities for assigned programs with focus on innovative ways of addressing barriers to development strategies as well as speeding the availability of our products to patients
Work with the rest of the argenx regulatory team, provide strategic regulatory guidance for assigned compound, help guide the organization on the appropriate filing strategy in primary regions, and coordinate across disciplines to ensure timely filings as applicable
Articulate global regulatory strategy to Sr. Management
Partner across all functions of the asset teams to ensure regulatory input is provided in a timely matter to support business decisions
Ensure coordinated regulatory strategy across the regulatory leads on the indication development teams, the asset team and the broader global regulatory team
Collaborate with asset teams, IDTs and PMO/Reg PM staff to plan the global submission timeline for the asset and project resourcing requirements and to ensure regulatory strategies are aligned with broader organizational strategies
Oversee and mentor the members of the regulatory community
Stakeholder Engagement Build and maintain strong relationships with health authorities, external partners, and internal stakeholders to facilitate regulatory approvals.
Represent the company in external forums, conferences, or regulatory working groups to stay informed of regulatory updates and share insights.
Regulatory Intelligence Collaborate with the regulatory intelligence team and organizationally with Regulatory Policy to continuously assess regulatory requirements and changes in global markets to anticipate challenges and mitigate risks.

Benefits

This job is eligible to participate in our short-term and long-term incentive programs, subject to the terms and conditions of those plans and applicable policies.
It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.

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