Affiliate Regulatory Affairs Manager
For our client, Astellas Pharma Europe B.V., we are looking for an Affiliate Regulatory Affairs Manager .
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.
Who we're looking for
For this role, we are looking for candidates with a Masters Degree in Pharmacy or other Life Science and at least 3 years experience with Regulatory Affairs in a local affiliate. You can deal with most aspects of registration/quality and you have knowledge of Regulatory procedures within the Netherlands. You have excellent communication skills in Dutch and preferably also in English. Additionally you have good organizational and planning skills, you have a good eye for details and can handle a large volume of work . Knowledge of IT programs like Trackwise, Veeva Vault or Blue are strong advantages.
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 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 global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||32 - 40 hours per week|
Days of leave: 25 + 13
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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