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argenx

Develops antibody-based therapies for autoimmune diseases

Associate Director Ethics and Compliance

Regulatory Compliance & EthicsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • Four to seven years of regional biopharmaceutical industry experience in a relevant compliance function, including extensive experience within a commercial-stage pharmaceutical or biotech company.
  • Regional experience with launching new products or new indications, healthcare compliance systems, training employees, engagement of healthcare professionals, and transparency.
  • Ability to collaborate and communicate with cross-functional colleagues and senior leadership in a multicultural and multilingual global environment.
  • Strong interpersonal, oral, and written communication skills.
  • Ability to innovate, analyze, and solve problems with minimal supervisory input; anticipate and identify Ethics and Compliance and other business risks; think strategically and propose innovative solutions to compliance-related challenges.
  • Solid understanding of business goals and the legal, compliance, and regulatory landscape in Europe.
  • High degree of personal, professional, and corporate ethics, integrity, and responsibility.
  • Expertise in European corporate commercial healthcare law and regulation related to pharmaceutical product development and commercialization.
  • Expertise in relevant industry codes and guidelines.
  • Fluent in English.
  • Willingness to travel 25–30%.

Responsibilities

  • Advise business functions on compliance and evolve the Global Ethics and Compliance program in the region, ensuring consistency with organizational values and principles, fitness for purpose, and compliance with applicable legal and regulatory requirements.
  • Serve as an advisor to regional and local commercial and medical teams, providing compliance-based input and direction across the product portfolio.
  • Review and advise on interactions with patients and patient organizations, healthcare professionals, institutions, payors, regulatory agencies, and other external stakeholders.
  • Draft and implement policies, procedures, and guidance with the Head of Ethics and Compliance DM and Germany, Legal, and other Ethics and Compliance colleagues, ensuring compliance with applicable laws, regulations, and codes in the relevant countries and region, excluding cGMP, cGCP, and other GxP guidelines.
  • Support adherence to transparency reporting requirements and reporting obligations where required.
  • Conduct or assist with compliance-related investigations and allegations of misconduct as required.
  • Prepare and deliver Ethics and Compliance training and education to the organization, including field-based employees, on employee responsibilities, the Ethics and Compliance framework, and related policies and procedures.
  • Foster the company's strong ethical culture.
  • Provide high-quality and timely guidance across business areas, customer-facing activities, and country-specific compliance issues.
  • Lead and contribute to compliance projects, issues, and priorities across the Global Legal and Compliance function.
  • Perform other duties as assigned.

Desired Qualifications

  • A legal degree; other relevant accreditations or degrees are considered.
  • Other language skills, including Italian, Spanish, French, or German.
  • Regional experience in specialty markets, particularly rare diseases.

About the Company

argenx

Develops antibody-based therapies for autoimmune diseases

Argenx develops and markets antibody-based therapies for severe autoimmune diseases, turning immunology research into medicines. Its lead drug, efgartigimod (VYVGART), and the subcutaneous VYVGART Hytrulo treat conditions like generalized myasthenia gravis and CIDP by modulating the immune system through FcRn pathways. The company differentiates itself with antibody engineering and a co-creation model with academic and industry partners, plus a pipeline targeting FcRn-, complement-, and other autoimmune pathways and a global development footprint. Its goal is to provide effective antibody medicines for autoimmune diseases and broaden global patient access.

Company size
1,001-5,000
Company stage
IPO
Headquarters
Amsterdam, Netherlands
Founded
2008

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