Responsible Person (Wholesale) / Regulatory affairs specialist EL Pharma

EL PHARMA (PHOENIX group Representation Services) is a leading service provider with a notable growth track of records in serving both large and medium-sized partners across specialty, vaccines, established pharma and consumer health.
EL PHARMA is part of PHOENIX group, headquartered in Mannheim, Germany, which is the European leader in provision of services in the healthcare sector. With a presence in 29 healthcare markets, the company offers unique geographical coverage throughout Europe, making a vital contribution to comprehensive healthcare with more than 48,000 employees.

EL PHARMA will start its operations in Lithuania in 2026.

MAIN RESPONSIBILITIES:

• Be accountable for deployment of “best practice” framework of Quality and Compliance procedures and controls;
  
• Ensure compliance against GDP, ISO 9001, ISO 27001 and national/international requirements;
  
• Act as the Responsible Person in Wholesale distribution and ensure that compliance to the regulations are upheld;
  
• Act as the main point of contact for national competent authorities regarding regulatory matters.
  
• Work closely with the Baltics and Local Management in a matrix organizational structure;
  
• Provide Quality Assurance (QA) support to initiate, engage and escalate critical and major compliance issues through QMS processes (including deviations, CAPAs, change control, validation);
  
• Ensure the maintenance of the annual subcontractors and evaluation schedule to ensure compliance to process and QMS;
  
• Act as a quality assurance point of contact for the internal departments and customers to ensure compliance;
  
• Coordinate and manage product registration, notification, and lifecycle maintenance for pharmaceuticals, medical devices, food supplements and cosmetics. Ensure all submissions and documentation comply with applicable legislation and internal quality standards;
  
• Monitor regulatory changes and provide timely updates and strategic guidance to the partners and internal stakeholders.

4000-4700 €/mėn. neatskaičius mokesčių