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Reference No: J13438

Senior Regulatory Officer \ Regulatory Project Manager – Top 10 Pharma

Berkshire - 45 mins from Central London (free shuttle bus to office)

Salary & benefits
£40,000 - £47,000 plus car allowance
•Annual bonus scheme
•Private pension
•Private health cover
•Free Gym
•Other excellent benefits including shares

Company
A globally renowned pharmaceutical company is looking for a Senior Regulatory Affairs officer to join their Established Products team to be based from their offices in Berkshire.

Why work for our client?
• Employ over 70,000 worldwide and over 1600 in the UK alone
• A targeted and goal setting approach to their organisation transcends to their staff which keeps everyone motivated and hungry to progress
• 60% of their staff having been there longer than 5 years (a lot higher than industry average).
• Diversity – global presence,
• Great exposure – you will be working closely with Commercial, QA, PV, Med Info.
• Opportunity to take ownership of products and in house projects
• Amazing people to work with and work environment including on site gym

The Role
Reporting into the Regulatory Affairs Manager the Senior Regulatory Officer will be responsible for the presentation and accuracy of all documentation prepared and, where appropriate, submitted to the regulatory authorities who include UK, Ireland and Malta. However there will also be exposure to the EU/Global teams and the sales/marketing team.

The role is mainly post approval lifecycle and managing projects – see breakdown of responsibilities below.

Our client has the diversity to offer employees a range of opportunities which include global exposure and regulatory affairs progression depending on interest including labelling, artwork, regulatory intelligence etc.

Main Responsibilities:
•Maintain marketing authorisations for a specified portfolio
•Submit Variations (e.g. Safety and CMC)
•Update and develop national texts (e.g. SmPC, PIL and packaging artwork texts
•Liaise with Global Regulatory Affairs on regulatory issues.
•Liaise with external regulatory authorities – MHRA/IMB and MMU (where applicable to the product portfolio).
•Gain marketing authorisations for pharmaceutical products in the UK, Ireland and Malta (as applicable)
•Liaise with local commercial teams and communicate significant regulatory issues/developments to commercial and the potential impact on the business
•Product development
•Product Launches
•Promotional Material and Prescribing Information
•Develop and maintain regulatory Standard Operating Procedures as required.
•Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements.

Education and Experience:
•3-5 years in Regulatory Affairs
•UK/MHRA experience is essential
•Excellent oral and written communication and interpersonal skills.
•Attention to detail.

For more information on the position please contact Aman , Regulatory Affairs UK Consultant aman@regulatoryprofessionals.com or call on 0118 9522797.

I f you refer someone who we then go on to place, you would be eligible for £250 worth of shopping vouchers!

Please find the link to the results of our salary survey for 2014: http://www.pharmaceuticalsalarysurvey.com – a complementary hard copy can be ordered from the website.

Keywords: senior regulatory affairs officer senior regulatory affairs executive senior regulatory affairs associate pharmaceutical biotech UK MHRA EMA Berkshire Buckinghamshire Hampshire London Middlesex Surrey Thames Valley Home Counties

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