Regulatory Affairs Manager

Solliciteer op de website van het uitzendbureau

Are you experienced in Regulatory affairs in a local Affiliate, are you fluent in Dutch and do you have excellent communication skills? Then we are looking for you!

In this role, you work with assigned products. The purpose is to prepare, submit and conduct appropriate follow-up of new Marketing Authorization and Life Cycle Management applications to the national competent authorities. You provide regulatory guidance to multidisciplinary teams to ensure that development or maintenance activities to be performed in the context of approved business. The activities are performed in time and in compliance with applicable regulatory demands (legislation and guidelines) throughout the product's life cycle.

Responsibilities and tasks:

  • Ensure high quality labeling translation and compliant printed packaging materials of marketed products;
  • Stays updated on relevant EU and local regulations and guidelines;
  • Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons informed;
  • Acts as substitute for Affiliate RA lead when needed;
  • Ensure that processes, procedures and regulatory files are well documented in up to date and complete applicable archives, databases, repositories and trackers;
  • Ensure compliance with all applicable SOPs, WPDs and STLs and contribute to CAPAs in case of gaps and deviations;
  • In connection with submission of MA applications, variations and renewals etc provide translation and QRD check of Product Information and ensure quality assurance including linguistic check of these documents;
  • Communicate about submitted and approved Summary of Product Characteristics (SmPC) or/and the leaflets and make these available for internal and external (if applicable) use;
  • Submit and implement Risk Minimization Plans and additional Risk Minimization Measures conform internal and external guidance;
  • Cross functional collaboration and communication both at Affiliate and HQ level.
Arbeidsvoorwaarden

A temporary, fulltime position for at least one year within an international and dynamic environment. A position for at least 32-40 hours per week. Salary is based upon experience (range: €3000 - €4000)

Uren:
40

Over de werkgever

Astellas is a Japanese multinational pharmaceutical company employing over 18,000 people worldwide with global sales exceeding 10 billion euro. The group's EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The office is based in Leiden.

Vaardigheden

• Excellent knowledge of the Dutch language;
• MS Degree in Pharmacy or other Life Science or equivalent by experience;
• A minimum of 3 years experience in a Registration Department/ Quality department, dealing with most aspects of registration/Quality, with sufficient working knowledge of the subject area to require minimal supervision from the Manager. Knowledge of Regulatory landscape and procedures within the country/region;
• Proficiency in PC use with regard to word-processing, spreadsheets, database application, and internet;
• Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills. The incumbent should possess a meticulous attention to detail, and be flexible enough to successfully handle conflicting time pressures and a large volume of work. Must be able to work both alone and as part of a team, and have the ability to concentrate on large volumes of written/paper based work in an office environment.;
• A sound appreciation of the interactions and relationships of the department with other internal departments is expected.

Opleiding

Wo

Wat wij bieden

Salaris:
€ 4.000,-
tijdelijk
Nu solliciteren

Solliciteer op de website van het uitzendbureau

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Contactgegevens

Mirjam Stolker
071 566 57 24
m.stolker@werk.olympia.nl

Olympia Leiden
Kort Rapenburg 6
2311GC,  Leiden