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Associate Specialist – Global Regulatory Operations

priority vacature priority vacature



A temporary position for two years at a large pharmaceutical company

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 Associate Specialist you will report to the Associate Director, Regulatory Information Management.

De functie / The role

As Associate Specialist you will participate in a multidisciplinary project team. The goal of the project is to ensure that all regulatory submissions within the EU are following the upcoming New Veterinary Regulations (NVR) and systems are in line with the new EU Telematics landscape. You will support the implementation of a new business processes to adhere to the NVR and update/create relevant SOPs. Besides that, you will support the Global Regulatory Affairs teams in collecting and analyzing regulatory information in different IT-systems and assessing impact for registered products. Furthermore, you will ensure alignment between SPOR data and in-house Global information systems, update product related information as needed and contribute to the preparation of regulatory submissions/variations if required. Moreover, you will prepare and provide training on new requirements and e-submission platform to relevant stakeholders.

Het profiel / Your profile

• bachelor degree or proven related working experience of minimum 2,5 years in the pharmaceutical industry
• experience in participating in multi-disciplinary project teams
• (preferred) knowledge on EU Telematics landscape (IDMP, UPD, SPOR, CESSP)
• preferred experience with regulatory information systems and platforms (i.e.: CESSP, Veeva)
• experience with registration processes (e.g. document management lifecycle and regulatory procedures; knowledge on dossier content to be able to compare SPOR terminology with the dossier)
• excellent communication skills, hands-on mentality, accurate, efficient, pragmatic, flexible, service- and compliance-minded, able to work under (time) pressure and cultural awareness
• excellent oral and written command of the English language

Het aanbod / The offer

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

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference to DT/20-069-FMF, to Sandra van Putten: info@derksenderks.nl.
For further information, please call Sandra van Putten at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

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
Derks & Derks Detachering

Geplaatst op FMF: 20 juli 2020

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