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Job Details

Regulatory Affairs Co-ordinator

Company: i-Pharm Consulting
Location: Netherlands
Reference: C-RA-Netherlands
Closing Date: 02 Mar 18
Type: Permanent
Salary (£): Negotiable

Job Summary:

RA Co-ordinator, NetherlandsGlobal generics company is looking for an RA Co-ordinator to join their growing team. ...


RA Co-ordinator, Netherlands

Global generics company is looking for an RA Co-ordinator to join their growing team.

Job Title: Regulatory Affairs Co-ordinator
Location: Netherlands

Benefits: Above market rate salary + fantastic benefits package
Permanent contract

- Writing scientific texts for new products
- Translating patient package leaflets and updating the computer system (SAP) supplying texts for packaging materials
- Ensuring the entry and modification of registration files
- Compliance activities including checking and correctly interpreting regulations, submitting regulatory affairs, supervising variations Type I and II, and submitting requests for registration transfers of dossier updates
- Operating on renewals independently
- Assisting with the compilation and completion of registration dossiers
- Collecting all kinds of administrative documents (permits, GMP certificates, samples, etc.) from internal and external parties answering questions from authorities during national registration procedures for self-prepared registration dossiers
- Liaising and communicating with different departments in the various countries and government bodies
- Maintaining internal procedures and internal administration
- Other tasks include assisting the drug safety officer, consulting with managers and stakeholders, and analysing trends

- Fluent in Dutch and English
- Science degree
- Minimum 3 years’ experience in a medical / pharmaceutical environment
- Work experience in drug registrations
- Good communication, interpersonal interaction and organisational skills are essential

About i-Pharm Consulting:
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

To apply:
If you would like to discuss this vacancy further, please call Charlotte Miles on +44 (0)20 3189 7819, or email If this role is not suitable, Charlotte is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

Regulatory Affairs / Reg Affairs / RA / Regulatory Affairs Officer / Reg Affairs Officer / RA Officer / systems / variations / dossier / labelling / registrations / renewals / submissions / CMC / compliance / documentation / liaising / translation / Central Europe / Almere / Amsterdam / The Hague / Nederlands

Apply for this job: Regulatory Affairs Co-ordinator

Contact Information:

Address:  Head Office
212 New King’s Road London
Reasons to work for i-Pharm Consulting
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

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