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Regulatory Affairs Officer
The Regulatory Affairs Officer ensures compliance of B. Braun Medicals products with the regional regulations combining scientific, legal and business knowledge.
The Regulatory Affairs Officer is the link between Global Regulatory Affairs, the products and local regulatory authorities in Belgium and The Netherlands.
The Regulatory Affairs Officer contributes to the positioning of B. Braun Medical as a professional, value-adding, trustworthy partner, anticipating and responding to internal & external customer needs and achieving high customer satisfaction.
| Region | The Netherlands/Belgium |
| Department | QA-RA |
| Reporting Line | QA-RA Director |
| Employment | Full time |
| Start date | As soon as possible |
Job Description
- To monitor and guard timelines for license variations (part of Life cycle Management) and renewal approvals; BeNe end responsibility.
- To support in preparing submissions of license variations and renewals
- To review product labels & patient information leaflets
- To liaise and communicate with regulatory authorities & assist Global RA during negotiations with those authorities concerning marketing authorisations
- To act as a sparring partner & lead out of RA position for the Sales & Marketing department on regulatory/pricing aspects, guiding optimilisation of margins
- To update records of official prices & reimbursements; end responsibility
- To prepare & assist during submission of pricing dossiers
- Formal back-up responsible for Information & Publicity and Local Safety Officer for pharmaco-, materio- and veterinary vigilance
- To review company procedures and implement changes to the database system conform legislation in BeNe
- To keep up to date with national and international legislation, guidelines and customer practices & provide feedback to global RA
- To prepare & support at regulatory inspections
- To act diligently and according to corporate complaint guidelines through receiving, documenting & prompt forwarding of complaints/ADRs (Adverse Drug Reaction);
Education/Professional experience:
- Minimum Bachelor degree (in biological, physical, chemistry, applied & medical sciences and/or health economics) or equivalent by experience
- Minimum 2 years of experience in relevant role
Necessary skills/Attitude:
- Service minded & confident & tactful communicator
- Accurate & analytical numeric mind-set
- Pro-active collaborator with all departments & stakeholders
- Flexible & problem solver attitude
- Strategic & project management mindset
- Able to grasp new concepts quickly and translate the impact on the business
- Able to work under pressure and to strict deadlines
Knowledge:
- Professional IT literacy (Excel, MS office, database management)
- Thorough understanding of regulatory affairs & medical/medicinal product development
- Profound knowledge of medical & medicinal legislation
- Good understanding of pricing & reimbursement rules & procedure is a plus
- Excellent written and spoken Dutch & English skills, French is a plus
Wil je solliciteren?
Als je interesse hebt in deze functie, mag je je naam, cv en motivatie direct mailen naar hr.bnl@bbraun.com.
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