Regulatory Affairs
Il y a 6 mois
**Introduction**:
The vision of our client is to be the most responsible animal health company where employees, experts, partners and customers create togheter customizes animal health solutions for a better planet. Currently they are looking for a Regulatory Affairs & Quality Manager.
The main purpose of this position is to contribute to the local management of the registration and licenses maintenance of animal health products (veterinary medicinal products, feeding stuff, diagnostics, hygiene products, ) in Benesca (Belgium-Netherlands-Sweden-Denmark-Norway). Simultaneously, as Quality Manager you are the Responsible Person (following to GDP guidelines) for Belgium and Netherlands.
You will be a part of several international teams (Regulatory Affairs, Quality and Pharmacovigilance), with functional managers based in France and close contact with colleagues all over Europe. This role also works with various other national and international departments, such as marketing, supply chain, manufacturing, business as well as with external parties like health agencies, distributors, national institutes, etc.
You will work closely together with 1 experienced colleague who will be responsible for the local pharmacovigilance management of the affiliate and participate in day-to-day quality tasks such as complaint/deviation/CAPA management.
**Job description**:
**Functions, Duties, Tasks**:
Regulatory Affairs
- Provide leadership in the coordination of Benesca requirements, submissions, packaging updates and other local regulatory activities
- Management of national phases of both MRP/DCP and centralised procedures, including:
- Follow-up on time-tables
- Organising and follow-up of translations and mock-up review
- Liaising with national authorities in Belgium, Netherlands, Sweden, Denmark and Norway
- A strong focus in the first years on the implementation of QRD template v 9.0.
- Management of national licenses and notifications (distribution, narcotics, feed,...)
- Budget preparation and management
- Regulatory Intelligence:
- follow both national and regional / international regulations, trade association meetings and Working Groups within the Benesca area
- Regulatory Information Management
- Maintain internal regulatory databases and electronic archives up to date.
- Advertising / Promotional material BE+NL
- Responsible for the review and approval of promotional material for pharmaceutical and non-pharmaceutical products to professionals and end-users.
- Training / support staff: give presentations on current legislation regarding registration and advertising
Quality Manager
Responsible Person for Quality Assurance for both pharmaceutical and non-pharmaceutical products for Belgium and Netherlands and back-up Responsible Person for Sweden.
- stay updated on both local and European regulation regarding GDP.
- ensuring that a quality system is implemented and maintained in the corporate IT Qualitytool
- focusing on the management of authorised activities and the accuracy and quality of records;
- ensuring that initial and continuous **training programmes **are implemented and maintained in the corporate IT Qualitytool;
- coordinating and promptly performing any recall operations for veterinary medicinal products
- ensuring that relevant customer complaints are dealt with effectively
- ensuring that suppliers, customers and sub-contracted activities are audited and approved;
- ensuring that **self-inspections** are performed at appropriate regular intervals following a prearranged programme and ensuring that the necessary CAPA are put in place;
- deciding on the final disposition of returned, rejected, recalled or falsified veterinary medicinal products;
- documenting deviations and deciding on CAPA to correct deviations and avoid their reoccurrence and monitoring of the effectiveness of those CAPA.
- responsible for the** administrative release **of batches for pharmaceutical products in Belgium/Netherlands where relevant
**Profile**:
- Advanced degree in life sciences (e.g., veterinary medicine, toxicology, pharmacy, chemistry, etc.) or equivalent.
- Previous experience in hands-on working in regulatory affairs and/or quality management, ideally in a similar position
- Good computer skills (Word, Excel, knowledge of data management)
- Excellent interpersonal and communication skills
- Strong attention to detail
- Good planning and organizational skills
- Fluent **English **language and **Dutch** language (written and verbal), fluency in French is an asset.
**Offer**:
Your gross salary depends on experience and beside that you will find in the salary package:
- A net allowance
- Annual bonus
- Group insurance
- Health insurance
- Company car + fuelcard
- Mobile phone+ laptop
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