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Job Details

Regulatory Affairs Specialist

Company: Regulatory Professionals
Location: Hertfordshire
Reference: J32204
Closing Date: 05 Mar 18
Type: Full Time
Salary (£): Negotiable
Benefits: £40,000 - £60,000 (experience dependent), benefits

Job Summary:

Regulatory Affairs Specialist Regulatory Professionals are collaborating with a niche pharmaceutical company who are undergoing expansion. This specialised business are leaders within their field and are looking to branch out into more MENA regions.

Requirements:

Regulatory Affairs Specialist
Hertfordshire, UK
Permanent
Salary: £40,000 - £60,000 per annum (experience dependent) + Benefits
Job Ref: J32204
Regulatory Professionals are collaborating with a niche pharmaceutical company who are undergoing expansion. This specialised business are leaders within their field and are looking to branch out into more MENA regions.
Responsibilities include,
* Preparation and submission of Market Authorisation applications, variations and renewals
* Post marketing submissions in MENA and UK markets
* Involvement in an ongoing process of transferring Market Authorisations
* Reviewing and submitting artwork and labelling changes
* Liaising with external clients and partners as well as partner's regulatory teams
* Ensuring all processes are conducted in accordance to guidelines and Standard Operating Procedures (SOPs)
* Gap analysis of regulatory documents with the intention of identifying potential challenges and subsequent solutions

Requirements,
* Bachelor's degree or equivalent within Pharmaceuticals or life science
* Minimum of 4 years Regulatory Experience covering EU markets
* In-depth knowledge MENA or EMA regulations
* Experience in liaising with government authorities and trade organisations within Regulatory Affairs
* Strong verbal and written communication as well as the ability to manage multiple deadlines and react

Remember if this role is not suitable for you please feel free to forward this to anyone you feel would be suitable. If we successfully find a role for your recommendation we will give you £250 in vouchers of your choice.

Luton, Letchworth, Hertfordshire, Cambrdge, Bedfordshire, Regulatory, Development, Preauthorisation, post-authorisation, Europe, Middle East, Africa, Senior, Officer, Project, Manager

Apply for this job: Regulatory Affairs Specialist

Contact Information:

Address:  UK Office
3rd floor 33 Blagrave Street Reading
RG1 1LG
England
Tel:  +44 (0)118 9522 797
Website:  Visit Our Web Site

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