Regulatory Affairs Officer

327459BR
Oct 21, 2021
Belgium

Job Description

MISSION

Within the Pharmaceutical Affairs department, the Regulatory Affairs Officer is the expert regarding scientific knowledge for the products within the indicated therapeutic classes. The responsibility with regard to the products, primarily concerns registration matters, but also specific supporting tasks and the start-up / follow-up of projects.

MAJOR ACCOUNTABILITIES

• Registration of medicines according to different European and national procedures in line with the stipulated deadlines.
• Writing and keeping registration files and documents up to date and coordinating to other departments such as Market Access, QA, Logistics, Marketing and Sales.
• Answering questions from the government regarding all file parts.
• Passing on information from registration files to internal and external customers so that the medicines and the relevant information on the market conform to the approved registration files.
• Entering into and maintaining partnerships with the other Novartis development centers in Europe,
• Maintenance of registration files with regard to the generic product portfolio by, among others:
• Collecting and interpreting information from Novartis and government sources that is important for the most effective implementation of the registration activities;
• Prepare, implement and handle national, mutual (MRP) and decentralized (DCP) recognition procedures;
• Maintaining existing registrations (MRP, DCP, national) by performing variations and 5 annual renewals;
• The preparation and checking of national registration documents required for registration;
• Answering questions (all parts of the file) from authorities during national registration procedures for self-prepared registration dossiers and during MRP and DCP procedures concerning national documents;
• To this end, the RAO will perform the following tasks:
• Organizing translations of package leaflets and labeling;
• Checking translations of package leaflets and labeling;
• Preparation and approval of texts for packaging material;
• Reporting changes to the file due to variations or five-year renewals, based on the timely preparation and transmission of change requests;
• Checking artworks;
• Update Registration database and RA Launchplan;
• Answering questions linked to tenders and other supporting tasks (such as drawing up shortened leaflets, etc.);
• Being responsible for the assigned RA projects and their implementation;
• Update of the available RA follow-up lists

Minimum Requirements

EDUCATION AND EXPERIENCE

Diploma (industrial) pharmacist or equivalent studies in scientific direction


COMPETENCES

• Accurate, punctual, vigilant
• Open attitude
• Communication skills
• Autonomous
• Dynamic, enthusiastic and motivated
• Team spirit
• Trilingual (Dutch, French and English) and knowledge of German
• Loyal and reliable
• Analytical skills and scientific knowledge
• Organizational talent and commercial thinking
• Leadership over own projects
SANDOZ
COMMERCIAL OPS EUROPE SZ
Belgium
Vilvoorde
Research & Development
Full Time
Regular
No
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327459BR

Regulatory Affairs Officer

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