Regulatory Affairs Officer

il y a 2 jours

Vilvoorde, Belgique Sandoz Temps plein

**Major Accountabilities**:

- Registration of medicinal products according to different European procedures (mutual recognition procedures (MRP) and decentralized procedures (DCP)) 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, Supply Chain, Marketing and Sales.
- Passing on information from registration files to internal and external stakeholders so that the medicinal products and the relevant information on the market conform to the approved registration files.
- Collecting and interpreting information from Sandoz and government sources that is important for the most effective implementation of the registration activities.
- Maintenance of registration files (MRP, DCP, national) by performing variations and 5 annual renewals.
- To this end, the RAO will perform the following tasks:

- Preparing and reviewing of national registration documents required for registration;
- Answering questions from authorities regarding national variations (all parts of the file) and national documents during MRP/DCP procedures/variations;
- Organizing translations of package leaflets and labeling;
- Checking translations of package leaflets and labeling;
- Preparation and approval of texts for packaging material;
- Initiating changes to the artwork 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 abbreviated SmPCs, review of the abbreviated SmPC in promotional materials etc.);
- Update of the available RA follow-up lists;
- Request CNK codes for new launches
- Start-up and follow-up of own RA projects and/or participate in projects.
- Local activities regarding Risk Management Plan (RMP)/Risk Management Activities (RMA)/Dear Healthcare Professional Communication (DHPC), such as the preparation, submission and follow-up of RMA/DHPC dossiers at the Belgian and Luxembourgian Health Authorities

**Education and Experience**:

- Diploma (industrial) pharmacist or equivalent studies in scientific direction
- 3 years in similar position

**Competencies**:

- 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

null
null

  • Regulatory Affairs Officer

    il y a 2 semaines

    Vilvoorde, Belgique Tessenderlo Group Temps plein

    Company Description- Job DescriptionAs Regulatory Affairs Officer you act as a link between the company and the regulatory authorities to ensure that products manufactured and distributed are in compliance with appropriate legislation. You specifically focus on trade legislation and support the BU in all import/export related matters, but also deal with...

  • Vice President of European Public Affairs

    il y a 2 jours

    Vilvoorde, Belgique Novartis Temps plein

    **Summary**: Location: Belgium, hybrid working 12 flexible working days per month in the office. About the role: As the Vice President of European Public Affairs(PA), you will be a dynamic and visionary leader, directly reporting to the Head of Global Public Affairs. This role is pivotal in managing enterprise government affairs and serving as a key member...

  • Manager Patient Safety

    il y a 2 jours

    Vilvoorde, Belgique Sandoz Temps plein

    Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture...

  • Sso Study Start-up Manager

    il y a 3 heures

    Vilvoorde, Belgique Novartis Temps plein

    100,000+ That’s how many patients participate in our clinical trials at any given time. GCO is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine -...

  • Grid Expert

    il y a 2 semaines

    Vilvoorde, Belgique Goodman Temps plein

    Always wanted to challenge the obvious and make great things happen? At Goodman we create space for your greatness. As a Grid Expert, you will play a crucial role in managing the energy infrastructure across our portfolio in Belgium and The Netherlands. You will be responsible for engaging with key stakeholders such as Distribution Network Operators (DNOs)...

  • Asset Manager Solar Pv

    il y a 3 heures

    Vilvoorde, Belgique Goodman Temps plein

    Always wanted to challenge the obvious and make great things happen? At Goodman we create space for your greatness! **More concretely, this means you will get the opportunity to**: - Monitor asset performance: - Monitor the performance of solar PV assets to ensure they meet or exceed performance expectations. - Analyse operational data and performance...

  • Clinical Supply

    il y a 3 semaines

    Vilvoorde, Belgique Adecco Temps plein

    Key Responsibilities :- Coordinate, support, and perform logistical and administrative tasks to support the team - Support daily operations related to study drugs, comparator products, and ancillary materials - Ensure compliance with internal procedures, quality standards, and client requirements- Manage the receipt, ordering, storage, labeling, inventory...

  • Network Engagement Lead

    il y a 2 jours

    Vilvoorde, Belgique Astellas Pharma Europe Temps plein

    **About Astellas**: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and...

  • Project Manager Ev Charging Infrastructure

    il y a 3 heures

    Vilvoorde, Belgique Goodman Temps plein

    Always wanted to challenge the obvious and make great things happen? At Goodman we create space for your greatness! **More concretely, this means you will get the opportunity to**: - Conduct comprehensive feasibility analyses for EV charging infrastructure development on our sites, including technical assessments. - Lead and manage EV charging...

  • Project Manager Solar Pv

    il y a 2 jours

    Vilvoorde, Belgique Goodman Temps plein

    Project Manager Solar PV Vilvoorde Always wanted to challenge the obvious and make great things happen? At Goodman we create space for your greatness! More concretely, this means you will get the opportunity: - Project planning and feasibility studies: - Conduct comprehensive feasibility studies, including site assessments and technical evaluations. -...