Nominated Signatory / RIP

Responsible for Information and Publicity – RIP

Belgium & Luxembourg (BeLux)

Role Purpose

The Responsible for Information and Publicity (RIP), is accountable for ensuring that all information, promotional activities, and communications related to medicinal products and medical devices comply with applicable Belgian and Luxembourg legislation, EU regulations, and industry codes.

The role covers AstraZeneca BeLux operations and relevant global activities involving Belgian/Luxembourg healthcare professionals (HCPs), non-HCPs, healthcare organisations (HCOs), and patient organisations (POs).

In AZ, the Responsible for Information and Publicity is called the Nominated Signatory.

Key Responsibilities

Regulatory & Compliance Oversight

• Establish, maintain, and update internal frameworks and procedures for reviewing promotional and non-promotional activities.

• Ensure compliance with:

  • EU Directive 2001/83/EC

  • Belgian Law on Medicinal Products (25 March 1964)

  • Royal Decrees governing advertising, samples, and medical devices

  • Sunshine Act transparency requirements

  • GDPR and other applicable regulations

• Provide final approval for all promotional materials and activities.

Approval & Governance

• Review and approve activities and materials through key systems:

  • VEEVA CRM: donations, consultancy agreements, sponsorships, scientific events, and field activities

  • ENGAGE: advisory boards

  • NS Platform: global projects involving BeLux stakeholders

  • PROMOMATS (AZ & DS): promotional and non-promotional materials

• Maintain complete documentation of approvals for audit readiness.

Medical Information & Scientific Accuracy

• Oversee responses to medical information requests from HCPs and patients to ensure accuracy and compliance.

• Review internal product communications, training materials, and brand plans.

Transparency & Transfers of Value

• Ensure compliance with Sunshine Act requirements and ensure accurate and timely reporting on betransparent.be

• Act as primary liaison for transparency reporting.

Samples & Product Information Compliance

• Oversee compliance with regulations for product samples, including traceability and reporting.

• Certify compliance of product translations.

Policy, Training & Continuous Improvement

• Develop, maintain, and update SOPs and guidelines aligned with:

  • Local regulatory requirements

  • Pharma.be, IML, and MDEON codes

  • AstraZeneca global policies

• Lead and oversee training programs for:

  • Sales and medical representatives

  • Internal stakeholders on compliance requirements

Stakeholder Management & Advisory

• Provide proactive compliance guidance and risk assessments to: Marketing, Sales, Medical Affairs, Corporate Affairs, Diagnostics, RWE, and Value & Access teams.

• Partner cross-functionally to ensure compliant project execution.

Audits, Complaints & Governance

• Support audit planning and continuous improvement initiatives with EMEA Compliance.

• Act as first point of contact for:

  • Regulatory authority inquiries

  • Competitor complaints

• Coordinate internal and external complaint handling processes.

Leadership & Oversight

• Manage and supervise:

  • 2 Nominated Signatory Associates

  • Backup Nominated Signatory

• Ensure operational continuity during absences.

• Participate in internal governance committees (e.g., Contribution and Patient Centricity Committees).

Scope

• Full accountability for AstraZeneca BeLux promotional compliance.

• Oversight of global activities involving Belgian and Luxembourg stakeholders.

Qualifications & Experience

Essential

• University degree in Pharmacy, Medicine, or Veterinary Science

• Certified RIP (Responsible for Information and Publicity) accreditation

• Fluency in French, Dutch, and English

• Minimum 5 years’ experience as a RIP within pharma and/or medical devices

• Strong knowledge of:

  • Regulatory and compliance frameworks

  • Advertising and promotional rules

• Excellent communication and stakeholder engagement skills

• Strong attention to detail and documentation capabilities

• Structured, consistent, and compliance-driven approach

• Collaborative team player

Desirable

• Knowledge of GDPR

• Experience in people management

Key Stakeholders

Internal

• Sales & Marketing

• Medical Affairs

• Regulatory Affairs

• Corporate Affairs

• Compliance Team

• Nominated Signatory Team

External

• AFMPS-FAGG (Belgian authority)

• Direction de la Santé (Luxembourg authority)

• MDEON

• Pharma.be National Ethics Group

• IML

• betransparent.be

Global Remit

Operates as the legally responsible person for information and publicity in Belgium and Luxembourg, ensuring full compliance toward national authorities and alignment with AstraZeneca global standards.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.