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Principal regulatory affairs officer

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Salary: £40,000.00 per annum


Greater London, London

Job Advertiser

KeyPeople
Registered: 16 Jul '14
Postings: 0
Followers: 0, Following: 0

Job Reference: 22241

Job Duration:

Start date: ASAP

Description:

eachperson has the ability to make a difference. From the providers who sell and market our products to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission criticalrole. Here's how this role will help:
-Ensuring that a company's products comply with the regulations of the MHRA/HPRA

-Keeping up to date with international legislation, guidelines and customer practices in all countries that the company is exportingto

-Collecting, collating and evaluating scientific data that has been researched by colleagues

-Developing and writing clear arguments and explanations for new product licences and licence renewals

-Preparing submissions of licence variations and renewals to strict deadlines

*Monitoring and setting timelines for licence variations and renewal approvals
*Working withspecialist computer software and resources
*Writing clear, accessible product labels and patient information leaflets
*Advising scientists and manufacturers on regulatory requirements
*Project managing teams of colleagues involved with the development of new products
*Undertaking and preparing for regulatory inspections
*Reviewing company practices and providing advice on changes to systems
*Liaising with, and making presentations to, regulatory authorities
*Negotiating with regulatory authorities for marketing authorisation
*Specifying storage, labelling and packaging requirements

Industry: Pharmaceuticals

Salary: £40000 - £50000 per annum + bonus

Salary Benefits: bonus

Vacancy Type: Permanent

Job Skills: pharmaceuticals, regulatoryaffairs, publishing, MHRA, HPRA, writing, labeling, packaging, TOPRA, management, mentoring

Contact Name: Eddie Cooper

Website: -

Direct Application URL: -

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Position Details

Advert Ref: #2685184
Posted: 06 May '18
Visits: 322