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Regulatory Affairs Manager Artwork

priority vacature priority vacature


Temporary position to support the regulatory Affiliate team by coordinating artwork and product information

Het bedrijf / The company

Our client manufactures and markets high-quality drugs in a diversity of fields. The organisation has been undergoing substantial growth and expects to be a global top ten player. In Europe, our client produces, develops and markets products through a network of affiliated companies. The European R&D and manufacturing activities are concentrated in The Netherlands. The European organisation is located in Leiden but has a tight line all around the world. For the regulatory department they look for support. Therefore they would like to meet a committed Regulatory Affairs Manager for a enthusiastic team.

De functie / The role

As Regulatory Affairs Manager, your main responsibility will be to manage new/updates of the product information and artworks of registered products in line with the defined planning and applicable requirements and internal SOPs. You perform quality control of translations and contribute to the change control process of texts and artwork, and provide input to the implementation strategy of (shared) packs. Furthermore, you review and proofread final artworks before implementation in production, and you monitor and communicate to the stakeholders the status of artworks until implementation. In addition to these specific responsibilities, you support implementation locally of new initiatives, management tools or processes in cooperation with RA-EMEA. You ensure that processes, procedures and regulatory files are well documented in up to date and complete applicable archives, databases, repositories and trackers. You contribute to the RA-EMEA and affiliate Quality Management System. You ensure compliance with all applicable SOPs, WPDs and STLs and contribute to CAPAs in case of gaps and deviations. Furthermore, you secure timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions and you take part in affiliate product and launch teams to provide regulatory input and strategy advice.
You act as substitute for Affiliate RA lead as appropriate. By discretion of Regulatory Affairs Management and due to organization and workload, not all listed activities may need to be performed or additional responsibilities need to be handled.

Het profiel / Your profile

o At least a master degree in a relevant field such as life sciences or equivalent by experience.
o Around 3 years of experience in the registration department, dealing with most aspects of registration, with sufficient working knowledge of the subject area to require minimal supervision from the Manager.
o Knowledge of Regulatory landscape and procedures within the country/region.
o Proficiency in English and France language.
o Proficiency in PC use with regard to word-processing, spreadsheets, database application, and internet.
o 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.
o A sound appreciation of the interactions and relationships of the department with other internal departments is expected.

Het aanbod / The offer

o Diverse job in the pharmaceutical company.
o Interesting because of the specialist work in regulatory.
o Permanent contract with the possibility to grow.

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/19-181-FMF, to Sandra van Putten: info@derksenderks.nl. For further information, please call and discuss the opportunity with Sandra van Putten at number +31 (0)33 472 80 87.

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.




Derks & Derks Detachering
Leiden, The Netherlands

Geplaatst op FMF: 25 november 2019

Branche: Farma & Biotech, Medical
Functie: QA / regulatory
Opleidingsniveau: HBO / BSc, WO/academisch / MSc
Werkervaring: 2-5 jaar, 5-10 jaar