Head of Regulatory Affairs, Quality Assurance and Pharmacovigilance - Benelux

We are excited to recruit a Head of Regulatory Affairs, Pharmacovigilance, & Quality Assurance for Beneluxand Green Division. Preferably this position will sit in Belgium at our Nazareth location but we will also consider our Rotterdam, Netherlands 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 organisation.

As a BENELUX Cluster Lead and member of the Belgium Country Leadership Team, this position will support commercial activities while ensuring regulatory compliance of all products placed on the market by Perrigo, Omega Pharma Belgium and will take control of directing the local RQS teams (BE and NL) to achieve this common goal.

Responsibilities include;

• In close partnership with the corporate team, setting the BENELUX RA strategy and overseeing BENELUX registration / market access / maintenance procedures for all product types within the portfolio, ensuring their outcomes fulfil the business goals.
• Ensuring regulatory maintenance and compliance for assigned pharmaceutical products/portfolio as well as Medical Devices/Nutritional supplements/Cosmetics/Biocides/ Medicinal products to prevent any barriers to operate.
• Supporting commercial activities while ensuring regulatory compliance as BENELUX Cluster Lead.
• Participating as an active member of the Perrigo Belgium Country Leadership Team.
• As Benelux Cluster lead;
  • manage the Belgium RA and QA team, acting as deputy RP
  • act as RIP Belgium
  • manage The Netherlands RA Country Head RAPV
• Assuring the obtaining/ maintenance of approval status for all marketed pharmaceutical products, Nutritional supplements, Medical Devices, Cosmetics and Biocides including proactive suggestion of strategies when appropriate, and measures for regulatory safeguarding and defence of existing portfolio, as required.
• Overseeing communications with local authorities and external advertising challenge resolution when they occur.
• Assuring all necessary QA/PV activities are performed

Knowledge and experience:

• Educated to degree level in a relevant scientific discipline or equivalent
• Minimum 8, but ideally 10 years of experience in pharmaceutical/healthcare industry, within RA roles
• Ideally with experience in the interplay with Pharmacovigilance and Quality; with an established network of contacts that can be leveraged to enhance the business
• Detailed understanding of the workings of and key stakeholders in BENELUX Competent Authorities
• Prior involvement in Regulatory Authority GxP inspections
• Current awareness of legal framework and forthcoming legislation that will affect the Perrigo business
• Familiarity with regulatory matters pertaining to multiple categories of healthcare products reflected in the portfolio covered by the role (e.g. OTC Medicines, VMS, Medical Devices, Cosmetics, Biocides
• Experience of managing teams and able to demonstrate a track record of positive RoI from Regulatory teams they have lead
• Preferably proven experience of vendor qualification
• Strong leadership skills with excellence in negotiation, strategic thinking, prioritisation and effective delegation
• Excellent written and oral expression in the French, Flemish and English language. Dutch language skills preferred.