Principal regulatory affairs officer

Key People

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Job ID :

9380


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--St.Albans,St. Albans,


Key Skills :

pharmaceuticals, regulatory affairs, publishing, MHRA, HPRA, writing, labeling, packaging, TOPRA, ma


Salary :

£40000 - £50000 per annum + bonus


Date Posted :

06 Nov, 2017



Company Name :

Key People


Location1 :

St. Albans




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

each person 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 critical role. 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 exporting to

-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 with specialist 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


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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