Regulatory Affairs Officer / Back up Qualified Person - Belgium
We are looking for a Regulatory Affairs Officer / Back up Qualified Person BrightOwl managed [?] Still accepting applications
Project is currently here
Key Objectives and Responsibilities
The role will be to be the liaison between the company’s RA and QA department and to function as the backup Qualified Person in case of his absence.
You will be responsible for:
- Preparing, writing and updating of Part 2 (Chemical, Pharmaceutical and Biological/Microbiological information) for regulatory submissions of new and old veterinary medicinal products (both generic and non-generic).
- Maintaining regular contact with the R&D department, quality control department and production department for the follow-up of ongoing projects and studies, including the preparation of study protocols and the drafting of study reports (eg. validation studies, stability studies, etc.).
- Evaluation and approval of the Product Quality Reviews for the company’s registered products.
- Maintenance of the supplier audit program (contract manufacturers, API manufacturers, manufacturers of printed packaging materials etc.): updating of relevant SOPs, scheduling third party audits, performing of audits & drafting reports.
- Batch release and certification in case of the absence of the QP.
Work from home: Not Allowed
No. of Positions: 1
Skills and Expertise
Field of study
Is a big plus
Is a big plus
Detail requirement and what we offer
Desired Skills & Experience
Skills & competencies
- Strong technical background & analytical mindset.
- Proactive approach, able to take initiative and to work autonomously.
- Able to manage multiple projects and enquiries in an accurate, efficient and structured manner.
- Good administrative skills. Flexible and able to meet critical deadlines.
- Team driven, empathic and dynamic.
- Able to work under pressure and to manage multiple enquiries at the same time.
- Good communication and excellent organizational and problem solving skills.
- Eager to learn and develop new expertise.
- Proficient in English and French.