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Regulatory Operations Associate

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Temporary position for 12 months at a pharmaceutical company

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 tight lines all around the world. The organisation is looking for a motivated Regulatory Operations Associate.

De functie / The role

As an Regulatory Operations Associate you will be responsible to ensure timely preparation and submission of correspondence and applications to regulatory agencies, tracking and planning of such and document conformance to global publishing standards and style manuals. You will also be responsible for timelines and own resource management. You will participate in extended teams/projects/teams and ensure timely internal communication regarding regulatory filing status. In the position you will be considered a specialist in the field of electronic document management & style compliance, submissions management & publishing or regulatory information management. As a member of the project teams / task forces you are considered a regulatory operations expert. You will provide advice on technical quality of submission ready documents and completeness of planning and tracking information. Furthermore, you will ensure compliance with Regulatory Agency rules and guidelines pertaining to regulatory (including electronic) submissions. You will represent Regulatory Operations EU in local project teams. Ongoing maintenance of process documentation associated with Regulatory Operations / publishing activities is also part of your role. You will act as a liaison between members of Regulatory Affairs, QA and Operations in order to ensure timely submission of regulatory compliant and quality documents. Last but not least you will participate in the global testing and piloting of new electronic software tools (to include version upgrades), and submission types. You will supervise contract staff in the conduct of their duties. You will conduct trainings for new users in Regulatory systems and create job aides, process improvements, and training documentation.

Het profiel / Your profile

• at least a Bachelor degree
• some experience in Regulatory affairs
• proven ability to prioritize and multi-task with minimal supervision based on interactions with project team members
• good written and oral communication skills in English
• high integrity with respect to maintenance of proprietary, confidential information
• highly accurate and organized, oversees support activities
• affinity to work with IT systems and a problem solving mentality
• comes up with improvements by taken initiative and a proactive mentality
• flexible, stress resistant and a teamplayer

Het aanbod / The offer

• a diverse job at a pharmaceutical company
• an interesting job because of the international contacts
• a temporary contract for 12 months, with the possibility to extend

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/21-041-DD, 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 Secondment & Interim as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Is this not the job you are looking for? Please visit www.derksenderks.nl/nl/nieuwe-baan/vacatures for other challenging positions in pharma, food and medical.

Solliciteer hier
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Derks & Derks Detachering
Derks & Derks

Geplaatst op FMF: 18 februari 2021

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