Helaas is deze vacature inmiddels waarschijnlijk verlopen

Regulatory Affairs Officer (Full-time)

Key duties and responsibilities

Contribution to the preparation of the pharmaceutical quality part (CMC) of our registration dossiers and keeping these up to date (lifecycle management). Our dossiers are submitted for approval worldwide, in order to obtain marketing authorisations. Our main focus is the European market.

• Writing the pharmaceutical quality part of registration dossiers which are developed in-house
• Writing variation dossiers
• Responding to questions of competent authorities (local and EMA)
• Assessing study results and writing report

What we are looking for

• Degree/Master in Pharmacy or analytical chemistry
• Several years of regulatory experience in Veterinary or Human pharma industry
• Knowledge of European legislation and procedures concerning (Veterinary) medicinal product registration process
• Experience in working in a GMP/GLP environment
• Excellent knowledge of the English language (spoken and written)
• Knowledge of MS Office (Word, Power Point and Excel)
• Team player with good social and communication skills

What we offer

• A challenging and multifaceted position
• An inspiring and dynamic working environment
• A support from your colleagues to achieve the best results
• Competitive salary and good employee benefits

Location

During the introduction process you will work at the headquarters in Raamsdonksveer, the Netherlands. If you don’t live in the Netherlands now and wish to return to your home country after this training period, we will look into these possibilities together. Dopharma has affiliated offices in 8 European countries!

Dopharma is a family owned veterinary pharmaceutical company with its headquarters in the Netherlands. Dopharma delivers high quality Veterinary pharmaceuticals for livestock since its establishment in 1969. Started as a one-man business and has grown into a company with 10 production lines and approximately 300 employees. Dopharma’s products are sold in over 80 countries by 8 local subsidiaries and approximately 70 distribution partners. Dopharma produces antibacterial, antiparasitic and anti-inflammatory products as well as hormone preparations, corrective preparations and complementary feed. Together we work towards clever and sophisticated solutions in order to achieve the best results possible.

We are 100% dedicated to livestock and are committed to make a significant contribution to the future of livestock farming. Our mission is to use our expertise and knowledge to support the continuous development of livestock farming. Our focus is on creating innovative solutions and manufacturing high quality and effective products which are safe for animals, humans and their environment.

The identity of Dopharma:

• Our vision – Healthy livestock, healthy results
• Our mission – To use our knowledge to improve animal health
• Our motto – Working together towards success
• Our essence – Healthy livestock

Information

For more information, please contact Sandra Gielen, Manager Pharmaceutical Research Lab/Regulatory Affairs Officer. E-mail:
, tel. + 31 (0) 162 58 2000.
For detailed information about our organisation, we refer to our website
.

How to apply

Please send your application to Janneke Goesten, Human Resources.

Email:
 
Working together towards ‘tomorrow’s livestock farming’. Healthy livestock, healthy results. Best practice, innovation and cooperation for healthy animals and healthy food.

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