Regulatory Affairs Manager - Netherlands

Regulatory Affairs/Clinical Affairs Rotterdam, Netherlands


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

We are excited to recruit a Regulatory Affairs Manager for the Netherlands. This vital position will report to the Head of RA PV & QA for Benelux. Preferably this position will sit in our Rotterdam based location. This is a business-critical role and we are seeking a passionate Regulatory Affairs professional to inspire and drive continued success within our growing business.

This position will support commercial activities while ensuring regulatory compliance of all products placed on the market by Perrigo, Omega Pharma Netherlands and will take control of directing the Netherlands RA team to achieve this common goal.

Key Responsibilities

  • Responsible for the hands-on regulatory activities associated with bringing new products to market and commercial product maintenance for a variety of domestic and/or international regulated products.
  • Leads the RA team within the Netherlands.
    • Managing, guiding and training the team.
    • Driving process improvement within the RA department.
    • Working with functional managers to understand their business needs (e.g. introducing a new product, entering a new market) for acquiring necessary regulatory permits.
    • Establishing and maintaining good relationship with regulatory authorities.
    • Liaising with industry organisations on regulatory topics in scope of Perrigo’s portfolio.
  • Leads cooperation and cross-functional interaction with head office and other local departments, such as Marketing and Supply Chain.
  • Communicates pharmaceutical and scientific knowledge and knowledge of laws and regulations; Internal Trainings, Company Management Guidance.
  • Responsible for representing Perrigo / Omega Pharma Nederland B.V from an RA standpoint at local trade associations
  • Involved in QA and PV related activities as required.

                 

Knowledge and experience:      

  • Experience with registration processes and regulatory activities for OTC medicinal products, food supplements, medical devices
  • Knowledge of pharmaceutical / scientific terminology.
  • Knowledge of legislation and regulations on medicinal products, food supplements, medical devices
  • Knowledge and experience in the field of pharmacovigilance and quality systems such as GDP.
  • Experience with project-based work
  • Experience with people management
  • University educated: Pharmacist / Life-sciences or equivalent (by experience)
  • Excellent written and oral expression in the Dutch and English language.

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.