Professional Regulatory

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.

Perrigo is a leading global provider of over-the-counter (OTC) health products and wellness solutions that enhance individual overall well-being.
Originating from the former Omega Pharma, the European branch is today present in 30 countries with a strong local anchorage. You know us from brands like Physiomer, NiQuitin, XLS Medical, Zaffranax, Arterin, Dermalex, Biover, Galenco, Davitamon, Ymea, Lactacyd, Dexsil, Bional, Fytostar, Salus, Grünwahlder and Vitasil.

Perrigo Belgium is an organization with a dynamic, transparent and fast-paced atmosphere, characterized by an entrepreneurial and cooperative culture. We are excited to be recruiting a dedicated **Professional Regulatory & Quality Affairs **to join our **Regulatory, Quality & Safety Perrigo Benelux & Green Division team** to join our **Nazareth** based function (including the flexibility to work from home).

As **Professional Regulatory & Quality Affairs **you undertake any required Quality Assurance activities, identify and mediate compliance risks to the company and monitor also the compliance and execution of the quality systems of the various suppliers. You will be responsible to handle Regulatory Affairs activities required to submit, approve and launch new or changed products, as well as the maintenance of existing commercialized products. This position will collaborate closely with the regulatory, quality & safety colleagues Benelux & Green Division, and the Belgian marketing, sales & supply colleagues.

If you want to have a positive impact whilst working alongside brilliant people, then read on

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**Main Responsibilities**

Quality assurance (70%)
- As part of the team, you contribute to the development, implementation, continuously improvement of the Quality Management System Benelux & Green Division. Aligned with the latest versions of the Perrigo Policies & Procedures. As applicable, you write the local procedures and work instructions for Belgian local affiliate.
- You handle quality questions, deviations, non-conformities, CAPAs, and management of changes in a timely manner for the Belgian local affiliate. You act as back up for the Perrigo The Netherlands and the Green Division.
- You control the requests of Supply team related to retour of goods, and report to RP for accept/reject decision.
- In close collaboration with Supply team, you handle the reworks (e.g. initiated for promotional activities) in a punctual manner and according to corporate standards.
- For the medicines, you act as delegate of the RP for the handling of the Administrative Batch Control activities. You collaborate with corporate QA & the logistics provider if issues.
- You provide quality training within Perrigo Belgium; as required, you support in the quality training for Perrigo The Netherlands and Green Nord.
- You actively participate in audits of competent authorities (e.g. FAGG, FAVV, NVWA), as well as in the BIO/ECO certification audits by the notified body.
- Performing the qualification and approval of suppliers and customers of Perrigo Belgium; perform audits as applicable; engage into QA agreements.
- Ensuring that self-inspections are performed within the cluster at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place; act as auditor for Green Division and Perrigo Netherlands depending on experience.
- You take the lead to prepare & conduct and the Quality Management Review meetings, and frequent monitoring and reporting of the QA KPIs.
- Together with the Consumer Affairs Assistant, you review product quality complaints and support in the execution of the follow up actions.
- You support in the handling of field corrective actions, including recalls.
- Ensuring risk assessment philosophies and methodologies are used and applied (e.g. HACCP verification plans)
- Support Senior Quality colleagues in more complex files, and participate in Quality projects.

Regulatory affairs (30%)
- For your product portfolio, you handle artwork, promotional materials and advertisement challenges in line with companies procedures and national regulatory requirements.
- Develop and execute regulatory activities according to the business plans to assure new or changed products meet submission, approval and commercial launch goals.
- Negotiate - in collaboration with Senior RQS - with the health authorities to resolve regulatory issues (e.g. names, claims).
- Maintain regulatory files and data systems in compliance with SOPs.
- Represent regulatory affairs in project meetings for your product portfolio.
- Support Senior Regulatory colleagues in more complex files, and participate in Regulatory projects.

**Minimum Requirements**
- University Degree or equivalent; degree in food science, biological or chemical sciences, pharmacy, medici