Compliance

• Provides administrative support during filling and review of new product registrations and post-approval submissions
• Plan and coordinate regulatory submissions to ensure timely delivery
• Draft and organize regional administrative documents and liaise with internal teams for completeness and accuracy
• Work closely with Regulatory Operations and Country RA Managers to establish submission timelines and align on submission strategy and execution
• Oversee translation processes to meet EMA requirements
• Coordinates new product artwork development and/or artwork updates implementation
• Keep regulatory databases updated and ensure adherence to EU legislation and procedural requirements
• Act as a subject matter expert in workstreams and process improvement initiatives

Associate Liaison, Regulatory Affairs – Europe

• Coordinate the preparation, review, and submission of regulatory dossiers for new product registrations and post-approval submissions in the EU, UK, Switzerland, and non-EU SEE countries.
• Work with cross-functional project teams to develop and implement regulatory strategies, including scientific advice, pediatric investigational plans, and orphan designation.
• Identify regulatory risks and ensure alignment of regulatory strategies with project teams and business objectives.
• Accountable for interacting with regulatory agencies and Country RA teams to facilitate smooth submission, assessment, and quick approval of CTAs under the EU Clinical Trial Regulation.
• Serve as the primary regulatory representative to regulatory agencies and Country RA teams.
• Act as the Regulatory Affairs representative on assigned non-product related cross-functional teams.
• Develop and implement effective processes to meet business objectives and ensure compliance with regulatory requirements.
• Continuously build and maintain a sound scientific knowledge and expertise in assigned product areas and regulations.

Regulatory Affairs Liaison

• Promote compliance across ITC EMEA teams.
• Develop strategies to prevent non-compliance and fraud.
• Support and eventually lead internal/external audits.
• Follow-up on non-compliance issues and ensure resolution.
• Evaluate and improve our IT policies, standards and procedures.
• Identify and manage IT risks, threats, and vulnerabilities.
• Report on risk & compliance status, and escalate where needed.
• Collaborate closely with IT and risk management teams to enhance our security posture.
• Lead efforts toward ISO 27001 certification for expanding scopes.

IT Risk & Compliance Specialist

• - Ensure that all information and publicity materials related to medicinal products or healthcare products comply with applicable regulatory requirements
• - Review and approve communication materials intended for healthcare professionals or the general public (e.g. brochures, digital content, training materials, press releases)
• - Verify the scientific accuracy, consistency, and balance of product-related information
• - Ensure communications are aligned with approved indications and regulatory approvals
• - Act as a key contact between Regulatory Affairs, Medical, Marketing, and external partners
• - Contribute to risk prevention by avoiding misleading, promotional, or non-compliant communications
• - Monitor regulatory changes impacting information and publicity requirements

Regulatory Consultant, Information & Publicity

• Act as a key member of the EDRT establishing and growing the team in alignment with argenx culture
• Co-creation and implementation of innovative global regulatory strategies
• Ensure patient-centricity is embedded in regulatory strategy
• Represent EDRT within key early development governance forums
• Serve as the conduit between EDRT and asset teams to facilitate transition of programs
• Mentor and coach EDRT members
• Build relationships with internal stakeholders
• Monitor, interpret and communicate evolving global regulatory requirements
• Oversee regulatory affairs vendors involved in EDRT activities

See all jobs on JobTailor

Associate Liaison, Regulatory Affairs – Europe

Regulatory Affairs Liaison

IT Risk & Compliance Specialist

Regulatory Consultant, Information & Publicity

Early Development Global Regulatory Lead