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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

Functional titles : Pharmacist ,  Industrial Pharmacist ,  Veterinarian
Project Types : Permanent position ,
FTE : 100 %
Min.Experience : 3 year
Start Date : ASAP
End Date : N/A
Posted on : 21 June 2017

Project is currently here

Step 1
Application
Step 2
BrightOwl Screening
Step 3
BrightOwl Interview
Step 4
Company Screening
Step 5
Company Interview
Step 6
Budgets & Contracts
Step 7
Position filled

Project Description

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.

Others

Project FTE 100%
Work from home:   Not Allowed
No. of Positions:   1

Personality

Analytical thinking Approachability Proactivity Communicative Adaptability Creative thinking Efficiency Flexibility Interest in knowledge

Knowledge

Regulatory Requirements Regulatory part 2 Pharmaceuticals Animal Health Veterinary Medicine

Skills and Expertise

Analytical skills technical proactive administrative skills flexible communicative english French

Degree

Master industrial pharmacy regulatory affairs

Field of study

Veterinary Sciences (Optional)

Languages

English
Professional Proficiency
Is a big plus
French
Professional Proficiency
Is a big plus

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.