Regulatory Affairs Officer
il y a 4 jours
Freelance
- Pharmaceutical
- Are you interested in a project within Regulatory Affairs for a Top 10 bio-pharmaceutical company? Do you like administrative work and doing this in a process-oriented and precise manner? Then this is your chance
**Vacancy information**:
As Regulatory Affairs (RA) Officer, you are responsible for executing operational administrative RA activities. You will report to the Head or RA and you will work very closely with an experienced RA Officer.
Accountabilities:
- Assists the RA Manager/Officer upon preparation of the registration dossier, updates and/or variations thereof for submission at the Belgian and Luxembourg health authorities:
- Among other editing and/or correcting cover letters, completing templates, modification of documents related to marketing authorisation, editing of product information with track changes
- Modification of documentation in line with the instructions of the RA Manager/Officer
- Use of the documentation databases according to the current processes and procedures
- Creation of the electronic submission documents
- Archiving of all correspondence (internal and authority correspondence)
- Creation of consolidated approved dossiers (both paper and electronic version)
- Organising and review of translations of the product information (DU - EN)
- Collect answers and respond to regulatory authorities questions within required timelines
- Review and correction of product information on Compendium portal
- Update of internal databases (e.g. product database) and creation of such databases upon necessity
- Request of modifications and review of the changes made in the company’s registration tool
- Assisting Head of RA-QA, QA Manager, and QA administrator with support for communication due to complaints and/or recalls
- Supporting the QA team with internal classification of documents
- Management of invoices from the RA/QA department.
**Requirements information**:
- Bachelor or equivalent combination by education and experience
- A first experience in Regulatory Affairs is an asset
- Experience working with data entry systems
- You like to work in a precise, structured and process-oriented way
- Good spoken and written communication skills Dutch and English (French is a strong asset)
- Accuracy
- Integrity/confidentiality
- Flexibility
- Customer/Market minded
- Showing initiative
- Planning and organisation.
-
Regulatory Affairs Officer
il y a 6 jours
Asse, Belgique Novellas Healthcare Temps pleinPharmaceutical - Recently graduated with a medical/biomedical degree or do you already have some experience in Regulatory Affairs, then we would love to hear from you! We are looking for a Regulatory Affairs Officer. **Vacancy information**: **MAIN RESPONSIBILITIES**: - Accurate and timely submission of registration files for RX and OTC medicines in...
-
Regulatory Affairs Officer
Il y a 7 mois
Asse, Belgique Novellas Healthcare Temps pleinPermanent - Pharmaceutical - You ensure the planning and realization of the Regulatory Affairs activities in line with the established procedures (RA/RIP SOPs). Develop good contacts with customers where professionalism, image and impeccable quality are guaranteed. **Vacancy information**: **CORE ACTIVITIES** - Jointly responsible for realizing the...
-
Recently Graduated
Il y a 9 mois
Asse, Belgique Novellas Healthcare Temps pleinContract Recently graduated and already living in Belgium and willing to come to the exciting life sciences industry? The life sciences industry is vast, encompassing everything from pharma and biotech, to managing medical devices/equipment. **Vacancy information**: Product testing, neuroscience, cell biology and other scientific-led roles are probably...
-
Medical Advisor Hematology
il y a 2 semaines
Asse, Belgique Novellas Healthcare Temps pleinPermanent - Pharmaceutical - Ready for one of the biggest players in the pharmaceutical industry? They are looking for a - **Medical Advisor (MA) Hematology & Lymphoma BeLux**! **Vacancy information**: As Medical Advisor you are responsible for translating the Medical Affairs strategy into country specific tactics and implementing them together with the...
-
Pharmacovigilance Officer
Il y a 7 mois
Asse, Belgique Novellas Healthcare Temps pleinPermanent - Pharmaceutical - As a (Deputy) EU Qualified Person for Pharmacovigilance (EU QPPV) and (Deputy) Local Contact Person (LCP) you are responsible for detecting, assessing, monitoring and acting preventively on side effects of pharmaceutical products and for reducing the risk of any harm to patients. **Vacancy information**: Ensure the planning and...
-
Quality Affairs Manager
il y a 1 semaine
Asse, Belgique Novellas Healthcare Temps pleinPermanent - Pharmaceutical - We are looking for a Quality Manager to join their Quality Assurance Team with process and reporting requirements in line with company policy. **Vacancy information**: For our client - a growing leader in the Belgian pharmaceutical and healthcare ecosystem - is quality king. Considering their mission-critical pharmaceutical and...
-
Medical Science Liaison
il y a 7 jours
Asse, Belgique Novellas Healthcare Temps pleinPermanent - Pharmaceutical - Do you want to support and develop our client's scientific presence through its innovative portfolio?**Vacancy information**: As a Medical Science Liaison within the Benelux dermatology medical department, in the Walloon region, your mission is in therapeutic areas of expertise: - To provide scientific and medical information in...
-
Clinical Study Manager
il y a 4 jours
Asse, Belgique Novellas Healthcare Temps pleinUndefined - Are you a skilled project manager with experience in the pharmaceutical industry? Are you ready to take on complex projects and lead teams to achieve objectives? We are seeking a Clinical Study Manager to join a medical team and manage clinical studies. **Vacancy information**: As a Study Manager, you will be responsible for leading complex...
