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Regulatory Expert for Medicinal Product Supply Chain

1 maand geleden


Amsterdam, Noord-Holland, Nederland The European Medicines Agency (EMA) Voltijd

The European Medicines Agency (EMA) is seeking a highly skilled Regulatory Expert to support the management of medicinal product shortages and ensure the availability of essential medications for patients.

We are looking for an individual with a strong background in scientific disciplines, such as pharmacy, chemistry, or biology, who can demonstrate at least 3 years of professional experience in managing shortages, supply chain, and manufacturing of medicinal products for human use and/or medical devices.

Key responsibilities will include:

  • Management of assigned shortage cases, ensuring timely and relevant communication between stakeholders to mitigate and manage shortages
  • Discussion of escalated cases with the Medicine Shortages SPOC Working Party
  • Identification of potential shortages that could lead to major events for discussion at the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG)

In addition to your technical expertise, you will need to possess excellent interpersonal and communication skills to interact effectively with patients, healthcare professionals, academia, pharmaceutical and medical device industry representatives, and other stakeholders.

The ideal candidate will have a university degree (minimum of three years) in a relevant scientific discipline and be proficient in English, with a satisfactory knowledge of another official language of the European Union.

This role offers a challenging opportunity to contribute to the EMA's mission of protecting public health and promoting innovation in the field of medicinal products. If you are a motivated and detail-oriented individual with a passion for regulatory affairs, we encourage you to apply for this exciting position.

Responsibilities and Requirements

Job Description

  • Regulatory Expertise: The successful candidate will have a deep understanding of EU regulatory frameworks, including those related to medicinal products and medical devices.
  • Supply Chain Management: Experience in managing shortages, supply chain, and manufacturing of medicinal products for human use and/or medical devices is essential.
  • Communication and Interpersonal Skills: Excellent communication and interpersonal skills are required to interact effectively with various stakeholders.
  • Language Proficiency: Proficiency in English, with a satisfactory knowledge of another official language of the European Union, is necessary.

Benefits

The EMA offers a competitive salary package, including a base salary of €6,418.36 per month, plus benefits, to attract and retain top talent in the field of regulatory affairs. As a member of our team, you will have opportunities for professional growth and development, working on high-profile projects that impact public health and drive innovation in the sector.

Location

The selected candidate will be required to relocate to the Netherlands to take up duties, joining a dynamic and diverse team at the EMA's headquarters in Amsterdam.