Associate Director, Regulatory Affairs

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

📋 Description

• Formulate and execute a comprehensive US regulatory strategy for designated projects.

• Offer strategic, operational, and tactical regulatory guidance on pre-approval and post-approval endeavors centered on the US market.

• Lead and coordinate initiatives related to regional strategy.

• Act as the main liaison with the FDA.

• Lead or partake in FDA meetings and prepare company representatives for interactions with the FDA.

• Direct and supervise the compilation of dossier materials for INDs, BLAs, and NDAs.

• Thoroughly evaluate submission documents to ensure regulatory compliance.

• Guarantee prompt, strategy-aligned responses to inquiries from the FDA.

• Engage in the development of labeling documents and negotiation strategies.

• Contribute insights into clinical study design strategies.

• Collaborate with medical, legal, quality, pharmacovigilance, and distribution teams to provide timely regulatory insights for business decisions.

• Observe, analyze, and communicate updates regarding the US regulatory environment.

• Keep track of the competitive landscape, including regulatory precedents, labeling variations, and therapeutic-area challenges.

• Contribute to global regulatory strategies throughout the product lifecycle.

• Advise on and facilitate product launches and commercialization efforts.

⛳️ Requirements

• At least 8 years of experience in regulatory affairs within biopharmaceutical companies.

• A minimum of 3–5 years in global leadership roles with a concentration on FDA matters.

• PhD or PharmD is preferred.

• Previous experience in rapidly expanding pharmaceutical firms is advantageous.

• In-depth knowledge of the drug development process.

• Expertise in orphan drug regulations.

• Familiarity with the evolving landscape of global regulations and guidelines.

• Proven ability to coordinate essential regulatory documents for medicine approvals, particularly concerning the FDA.

• Strong affinity for science and capacity to collaborate with scientists and clinicians.

• Required experience in interacting with regulatory authorities.

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

• Awareness of 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 effectively.

• Excellent written, verbal, and presentation communication skills.

• Capacity to build relationships and collaborate across the organization.

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

• A pragmatic, creative, and innovative mindset.

• Strong leadership qualities with the ability to inspire, motivate, and develop a team.

• Alignment with argenx values and company culture.

• Strategic thinking with the capability to execute individually and lead teams in a matrixed environment.

🏝️ Benefits

• Short-term incentive programs.

• Long-term incentive programs.

• Retirement savings plans.

• Health benefits.

• Additional benefits in accordance with applicable plans and program guidelines.

• Equal consideration in an inclusive and non-discriminatory setting.

• Reasonable accommodations during the application and selection process.