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Senior regulatory officer

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Salary: £35,000.00 per annum


Greater London, London

Job Advertiser

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

Job Reference: 22116

Job Duration:

Start date: ASAP

Description:

-Ensure suitable dossiers (marketing authorization applications / post-approval submissions) are prepared and dispatched on-time for products in designated EU and non-EU territories.

-Ensure databases and systems are maintained in accordance with current SOP's to fulfill regulatory obligations.

-Work closely with internal and external parties, establishing effective communication channels and excellent working relationships to progress regulatory activities.
-Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.

-Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental
procedures and processes.

-Support Line Manager through participation in project teams; and mentoring/training junior team members

Industry: Pharmaceuticals

Salary: £35000 - £44000 per annum + bonus

Salary Benefits: bonus

Vacancy Type: Permanent

Job Skills: pharmaceuticals, regulatory affairs, regulatory, publishing, eCTD, EXTEDO, MAA's, post approval, submissions, SOP's

Contact Name: Eddie Cooper

Website: -

Direct Application URL: -

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Position Details

Advert Ref: #2684879
Posted: 07 May '18
Visits: 234