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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
Benefits:

Job Summary:

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

Requirements:

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

Responsibilities:
- 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

Requirements:
- 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.

www.i-pharmconsulting.com

To apply:
If you would like to discuss this vacancy further, please call Charlotte Miles on +44 (0)20 3189 7819, or email cmiles@i-pharmconsulting.com. 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.

Keywords:
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
SW6 4NZ
England
Reasons to work for i-Pharm Consulting
Tel:  +44 (0) 20 3189 2299
Website:  Visit Our Web Site

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