Regulatory Affairs Specialist

  • Brabant
  • 4500.00 - 5500.00
  • 32-40 uren
  • Bachelor degree

Opdrachtgever

Our client is a leading project management and engineering company for industry around the world.

Opdrachtgever

Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence.
They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.

functie Vereisten

  • BSc in Pharmacy or other Life Science.
  • Experience in the pharmaceutical Industry in a regulatory, medical or quality position and a minimum of 3-year experience in a Registration Department.
  • Expertise in the following fields is preferred: Extra-EU RA (UK, CH) and Biosimilars.
  • Expertise in handling the regulatory aspects of Business Deals is preferred.
  • Experience in handling regulatory requirements for Medical devices both alone and in combination with medicinal products is preferred.
  • Ability to communicate well verbally and in writing is essential, as are good organizational and planning skills.
  • Possess a meticulous attention to details 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 able to concentrate on large volumes of written/paper-based work in an office environment.
  • Proficiency in English language as well as PC use with regard to RA Company’s systems and tools, word-processing, spreadsheets, database application, internet.

Wat krijg je?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Werkzaamheden

  • Perform timely and correct preparation of assigned new Marketing Authorization applications.
  • Tracks process on products registration and new indications.
  • Reviewing Modules 2, 4, 5 and coordinate how handling Module 3.
  • Ensure timely preparation and maintenance of the Product Information (Summary of Product Characteristics, Patient Package Inserts, labelling) and other applicable regulatory documents.
  • Ensure efficient and consistent implementation and use of internal and external regulatory databases, systems, tools.
  • Ensure that files and archives related to Regulatory are kept updated and complete.
  • Participates in maintaining relevant Standard Operating Procedures to secure that the current regulations are complied with.
  • Secure timely and adequate information and decision making with regard to regulatory issues.
  • Adequately support other functions to enable compliance in areas related to regulatory, such as PSUR submissions.

TAGCLOUD

regulatoryaffairs
#RA
#pharma
#GMP
#module3
#submissions
#labelling
#artwork
#documents
Peter Debrichy

Geïnteresseerd?

Send your resume to peter@tailorminds.com referring to job id (1030)

Meer informatie?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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