Sr. Director Asset Regulatory Affairs Lead

Location: Indiana

argenx is a global immunology company developing antibody-based medicines for patients suffering from 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.

Preferred

locations

Belgium, Switzerland, 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 either near Boston, Belgium or Switzerland.

Your primary areas of focus are

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

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.

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.

Desired Skills and Experience

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 Pharm

D 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…