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Regulatory Affairs Officer

Challenging position for the real go-getter within Regulatory Affairs for a large international pharmaceutical company.

Job Description

We are looking for an experienced person to fill this challenging all-round position. Focus areas will be: Regulatory Submissions, Labeling and Artwork, coordination of Modules 2, 3, 4 and 5, and much more. The duration of this position initially is 6 months.

Responsibilities

  • Coordination for new and authorized pharmaceutical product through timely preparation for submission of variations, renewal applications, PSURs and any other necessary application/notification.
  • Responsible for correct/complete intake of the documents and procedure that trigger initiation of introductions / changes.
  • Collecting all necessary information for preparation of new product labeling, such as technical specifications, design specifications, registration requirements and texts.
  • Reviewing Modules 2, 4 and 5 as well as coordination of Module 3 improvements (CMC or other programs).
  • Contact person for internal and external stakeholders such as, Packaging sites, External artwork center, Regulatory entities, Supply Chain-, Regulatory- and QA-departments.

Requirements

  • Bachelor degree in a life science related field.
  • Excellent communication skills (fluent in English) as well as organization and planning.
  • Senior level working experience in a fast paced environment with high volumes of work within RA or related field.
  • You are focused, determined, problem solving, and business keen.
  • You have a valid work permit for EU.

Benefits

  • Contract: 6 months via Oxford.
  • Salary: €4000 - €5500 gross monthly based on 40 hours.
  • Working hours: 32-40 hours.
  • Region: Oss.
  • Vacancy number: 18594.