Responsible Person (RP) Wholesale & Medicinal Cannabis

About the role

The company is a growing pharmaceutical cannabis business operating in Germany. It seeks an experienced Responsible Person (RP) to oversee wholesale distribution and medicinal cannabis activities, ensuring full compliance with German and EU regulations.

Key responsibilities

• Act as the Responsible Person for wholesale distribution under the German Medicinal Products Act (AMG) and the AM‑HandelsV, ensuring compliance with GDP requirements.
• Oversee receipt, storage, handling, transportation, and temperature monitoring of medicinal products.
• Maintain and update GDP‑related SOPs, procedures, records, and documentation.
• Approve and review suppliers, customers, and subcontractors for GDP compliance.
• Implement and monitor GDP training for relevant staff.
• Coordinate product recalls, investigations, and complaint handling.
• Decide on disposition of returned, rejected, or recalled products and approve returns to saleable stock.
• Serve as primary contact for inspections and regulatory enquiries.
• Act as the Responsible Person for medicinal cannabis under the MedCanG, securing required permits and ensuring compliance with Sections 4‑16.
• Participate in supplier audits and regulatory inspections, managing corrective actions.

Required profile

• Proven experience in pharmaceutical wholesale distribution and regulatory compliance.
• In‑depth knowledge of the German Medicinal Products Act (AMG), AM‑HandelsV, EU GDP guidelines, and the German Medicinal Cannabis Act (MedCanG).
• Strong understanding of permit acquisition and maintenance for medicinal cannabis activities.
• Ability to develop, review, and maintain SOPs and quality documentation.
• Excellent organizational skills and the capacity to act as the main liaison with competent authorities.

Required skills