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Project Leader (Senior Specialist) – Global Regulatory Operations

priority vacature priority vacature


Het bedrijf / The company

Our client is a world leader in the healthcare industry. Through their medicines, vaccines, biological therapies, and support services they offer health solutions for people and animals in more than 140 countries. They also demonstrate their commitment to an increasing access to healthcare through far-reaching programs that donate and deliver their products to the people who need them. The organisation has three main locations with approximately 4,500 employees. This position is located in Boxmeer. The location has approximately 45 employees who are responsible for marketing, sales, distribution and support of the products. As Project Leader you will report to the Associate Director Regulatory Information Management.

De functie / The role

As a Project Leader you will lead a multidisciplinary project team that is in charge of the New Veterinary Regulations (NVR). You will develop and execute project plans to ensure that the company’s business processes as well as regulatory information systems and platforms are in line with the new EU Telematics landscape. The scope of the project includes both biological (vaccines) as well as pharmaceutical products.
It is your task to maintain direct contact with internal stakeholder groups and assess regulatory impact for approved products. You will work closely with other Global Regulatory Affairs department to ensure preparation and execution of product variations if required. You will closely follow discussion at EMA and Industry Association and participate to external meetings/working groups when needed. Besides this, you will provide clear and timely communication with project team members and towards sponsors/steering committees and escalating issues/concerns when needed. Furthermore, you will provide clear and timely communication towards all globally-impacting colleagues and provide the necessary training.

Het profiel / Your profile

• bachelor professional and intellectual ability
• profound experience in the pharmaceutical industry (focus on: Regulatory Data Management, Quality Management, Manufacturing, Supply Chain or Compliance)
• knowledge on EU Telematics landscape (e.g. IDMP, UPD, SPOR, CESSP)
• experience with regulatory information systems and platforms (i.e.: CESSP, Veeva) and EU registration processes
• accurate, efficient, pragmatic, flexible, teamplayer, service- and compliance minded, able to work under (time) pressure and cultural awareness
• projectmanagement and communication skills
• excellent oral and written skills of the English language

Het aanbod / The offer

• a challenging job within a large pharmaceutical company
• a temporary two-year contract
• contract at Derks & Derks Secondment & Interim

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-070-FMF, to Sandra van Putten: info@derksenderks.nl.

For further information, please call 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.
More vacancies? Click on the link: http://www.derksenderks.nl/vacatures

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Derks & Derks Detachering
Derks & Derks Detachering

Geplaatst op FMF: 20 juli 2020

Branche: Healthcare
Functie: Management
Opleidingsniveau: HBO / BSc, WO/academisch / MSc
Werkervaring: 0-2 jaar, 2-5 jaar, 5-10 jaar, > 10 jaar