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Job Details

Regulatory Senior Officer

Company: Regulatory Professionals
Location: Hertfordshire
Reference: J30994
Closing Date: 14 Dec 17
Type: Full Time
Salary (£): Negotiable
Benefits: Pension scheme and 31 days holiday

Job Summary:

Regulatory Senior Officer Regulatory Professionals are working with a rapidly expanding pharmaceuticals company who plan to continuously grow and develop within their niche market.

Requirements:

Regulatory Senior Officer
Hertfordshire, UK
Permanent
Salary: £40,000 - £50,000 per annum (experience dependent) plus pension scheme and 31 days holiday
Job Ref: J30994

Regulatory Professionals are working with a rapidly expanding pharmaceuticals company who plan to continuously grow and develop within their niche market.
The Role:
* 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

The ideal candidate will have the following:
* Bachelor's degree or equivalent within Pharmaceuticals or life science
* Minimum of 3-4 years Regulatory Experience
* In-depth knowledge of MHRA, EMA, and MENA 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 decisively

Apply for this job: Regulatory Senior Officer

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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