Director, Regulatory Affairs

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop and execute a comprehensive US regulatory strategy for assigned projects.

• Offer strategic, operational, and tactical regulatory insights on pre-approval and post-approval activities with a focus on the US.

• Lead and coordinate efforts related to regional strategy.

• Act as the primary liaison with the FDA.

• Oversee and manage interactions with health authorities, including briefing packages, response documents, and FDA correspondence.

• Direct and supervise the preparation of dossier content for INDs, BLAs, and NDAs.

• Perform critical reviews of submission documents to ensure regulatory compliance.

• Guarantee timely and strategically-aligned responses to inquiries from the FDA.

• Engage in the development of labeling documents such as target product profiles, CCDS, and USPI.

• Contribute strategic regulatory input to clinical protocols, clinical and nonclinical reports, and summary documents.

• Collaborate with medical, legal, quality, pharmacovigilance, and distribution teams.

• Serve as the Global Regulatory Lead on projects as needed.

• Monitor, interpret, and communicate changes in the US regulatory landscape.

• Analyze the competitive landscape, including regulatory precedents, labeling differences, and issues within therapeutic areas.

⛳️ Requirements

• A minimum of 10 years of regulatory affairs experience within biopharmaceutical organizations.

• At least 5–7 years in global leadership roles focusing on the FDA.

• A PhD or PharmD is preferred.

• Previous experience in rapidly growing pharmaceutical organizations is desirable.

• Comprehensive understanding of the drug development process.

• Expertise in orphan drugs.

• Knowledge of the evolving landscape of global regulations and guidelines.

• Proven ability to coordinate critical regulatory documents involved in medicine approvals, particularly with the FDA.

• Strong affinity for science and capability to engage with scientists and clinicians.

• Experience in interactions with regulatory authorities.

• Ability to communicate and engage with diverse individuals on technical and business topics.

• Familiarity with current and emerging regulatory legislation, industry trends, and global healthcare business practices.

• Highly developed organizational and project management capabilities.

• Skills in strategic planning, delegation, resource allocation, and prioritizing workloads.

• Understanding of digital technologies and AI-enabled environments.

• Ability to utilize data-driven insights and innovative tools to shape regulatory strategy.

• Excellent communication and stakeholder influence skills.

• Exceptional presentation, written, and verbal communication abilities.

• Experience in people management, coaching, or mentoring is preferred.

• Strong leadership skills with the capacity to build, motivate, and develop a team.

• Ability to blend strategic thinking with execution in a matrix environment.

• Capability to thrive in a fast-paced, results-oriented, and highly accountable environment.

• Proficient in building relationships and collaborating across the organization.

• Alignment with argenx values and company culture.

🏝️ Benefits

• Short-term incentive programs.

• Long-term incentive programs.

• Retirement savings plans.

• Health benefits.

• Comprehensive benefits package.

• Equal consideration for employment without discrimination.

• Reasonable accommodations during the application, interview, or candidate selection process.