Senior Regulatory Affairs Officer - North West - Pharmaceutical
A fantastic opportunity has arisen for an experienced Regulatory Affairs professional to be part of a progressive leading pharmaceutical company as a Senior Regulatory Affairs Officer based in Leeds in the North West of England.
This family cultured company specializes in the development, manufacture and marketing of oral liquid medicines in a vast and varied product range including corticosteroids, analgesics, diuretics, antibiotics and anti-psychotics.
As Senior Regulatory Affairs Officer you will report to the Principle Regulatory Affairs Officer and be responsible for gathering documents, preparing MAA's and communicating with authorities.
Key Responsibilities:
*Prepare packaging including reviewing against excipient guideline, first pack check and Braille check and submit to external databases whilst liaising with user test team
*Arrange Type basic national variations and Type II MR variations
*Assess PSUR data
*Prepare National and DCP licenses
*Collate and submit Clinical Trial Applications and respond accordingly
*Provide regulatory expertise to internal staff and external contacts
The role will require you to possess First Degree in a relevant life science, you must have significant pharmaceutical regulatory experience, you will be a member of TOPRA, you must have experience of Type I and II variations, DCP, MRP and Marketing Authorization Applications (MAA's) and have experience of preparing and submitting documents for labels and leaflets. You should be a organized, proactive, results driven, positive, confident and motivated individual with exceptional attention to detail, communication skills, project management skills and problem solving skills. Some travel may be required for the role so you should be flexible.
This is an exciting opportunity within a career driven company offering excellent benefits including competitive salaries, a pension scheme, private healthcare, free parking, a reward scheme, attendance bonuses, a metro card scheme, childcare vouchers and a generous holiday entitlement.
Key Words - Pharmaceutical, Liquid Medicine, Regulatory Affairs, Regulatory Affairs Associate, Regulatory Affairs Officer, Regulatory Affairs Executive, Regulatory Affairs Advisor, Regulatory Affairs Officer, North West, Leeds
For further information on the role or company please contact myself, Amie Adams at Paramount Recruitment on 0121 616 3473.
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