job details for:
Pharmaceutical - Regulatory Affairs Executive Jobs - Manchester

Pharmaceutical - Regulatory Affairs Executive Jobs - Manchester (Job Ref: WR/JOBS/24848-11330)

Job Description :

Flame Pharma Pharmaceutical - Regulatory Affairs Executive Job - Manchester:

Job Summary

Flame Pharma are currently recruiting a Regulatory Affairs Executive to be based in our client’s offices in Manchester. The purpose of the Regulatory Affairs Executive will be to maintain product licences held by the Company, ensuring that they are kept up to date, notifying the Regulatory Authorities and making sure the process runs smoothly. They will provide support and deputise for the Senior Regulatory Executive as and when required.

Job Title

Regulatory Affairs Executive

Background

Due to expansion, our client are looking to recruit a Regulatory Affairs Executive to be based in their offices in Manchester.

Key Responsibilities

• Preparation and submission of applications for renewal, variation and change of ownership to the Regulatory Authorities in a timely and accurate manner, taking into consideration commercial needs
• Prepare responses to questions issued by the Regulatory Authorities
• Follow up with Regulatory Authorities on submissions and regulatory issues
• Request, review and submit all PSURs as required
• Direct negotiations and liaisons with 3rd party companies and other departments of the company concerning submission applications
• Writing, reviewing and advising on SmPCs and packaging
• Keep up to date with the latest guidelines and legislation, advising colleagues on implications of any changes.
• File maintenance and organisation
• Maintain smooth running of the regulatory department and the licensing update processes

Qualifications and Experience

The successful candidate should have hands on experience in a regulatory/licensing environment, with a good working knowledge of all the processes and legislative procedures that need to be adhered to by a pharmaceutical organisation.

A science based degree would be essential as there is a requirement to gain a sound technical understanding of clinical and manufacturing aspects of company products.

They must be an organised and accurate worker, able to plan ahead effectively, and work to and meet strict deadlines.

Benefits

• Salary circa £25,000
• Opportunity to earn an annual bonus of 7.5% of salary which is based on Company and Individual performance throughout the year
• 25 days holiday entitlement per annum, plus bank holidays
• Dental and Health Insurance paid by the company
• Contributory pension scheme.

Key Words

Regulatory Affairs Executive, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

This role is to be based in Manchester.

For further information about this role, please contact Flame Pharma.