Regulatory, Quality

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.

Green Nord (Ocebio NV, Ocebio BV) & Biover NV are suppliers of cosmetics, food(s) (supplements), medical devices, biocides, and general goods in the countries Belgium, Netherlands, Luxembourg, Spain, Portugal.
**Role Description**:
The RQS Manager Green Nord & Biover shall handle the regulatory activities required to submit, approve and launch new or changed products, as well as the maintenance of existing commercialized products for Green Division Nord & Biover.

On the other hand, the RQS Manager Green Nord & Biover shall handle complaints and adverse events/incidents, 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.
**Mission**:
Steer the transition of Green Nord & Biover into the Perrigo company & processes, while respecting the business specificities.

Support the Cluster Head to achieve efficiency & structure in the way of working, and full compliance to regulatory & Perrigo requirements.
**Key responsibilities**

Regulatory Affairs (50%)
- Manage 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 directly with 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 Ocebio & Biover.

Quality Assurance & Safety (50%)
- Ensure that a Quality Management System is developed, implemented and continuously improved; ensure it is aligned with Perrigo central QA standards, QA manager of BE, QA Manager NL & RQS Manager Green South (Cosmédiet).
- Handle deviations, retours & recalls, reworks, capas, management of changes in a timely manner.
- Provide training to the Green Nord & Biover team members.
- Act as primary quality contact point towards competent authorities (e.g. NVWA, FAVV).
- Performing the qualification and approval of suppliers and customers; audit as applicable; engage into QA agreements as applicable.
- 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 auditee for Green Nord, and as auditor for Perrigo Belgian and Perrigo Netherlands.
- Manage Quality Management Review meetings, and monitor QA KPIs.
- Ensuring that all customer complaints, adverse events/incidents, or inquiries are handled and reported in the Trackwise system as applicable in accordance with company’s SOPs.
- Notify and consult - in close collaboration with Corporate Safety - with the Competent authorities on potential recalls or critical quality issues which may impact patient safety.
- Act as primary contact point for safety activities (e.g. audits, agreements).
- Ensuring risk assessment philosophies and methodologies are used and applied.

**Requirements**:

- University Degree or equivalent; degree in food science, biological or chemical sciences, pharmacy, medicinal science or a related discipline; herbalist degree or any other specific interest or degree related is an asset as the portfolio is mainly based on herbs & plants.
Understanding of applicable regulatory requirements for cosmetics, food products; knowledge of regulatory framework for medical devices, general safety products and biocides is a strong asset.
- Dutch, French and English language knowledge is required.