Description
Regulatory Affairs OfficerSurrey
Up to 40,000
Description:
* In depth scientific knowledge - product knowledge
* Fast paced experience at high quality standards with clinical trial applications - variations - renewals - labelling
* Pursue maintenance activities for assigned portfolio to ensure on-going compliance with local and EU regulations and company procedures
* Aware of current / up to date on going activities and documents within allocated projects advising head of regulatory affairs and other stakeholders
* Analyse data to extract decision making and recommend actions
* Keep in mind legislation's and guidelines
* Develop good client work - working with contacts with personnel at the Health Authorities
* Monitor compliance and production routine
* Review promotional sales material to ensure compliance with registered product licence particulars
* Advice colleagues from Global regulatory affairs, EIURMEA regulatory affairs and manufacturing sites on local regulatory requirements
* Creation and maintenance of local Standard Operating Procedures (SOPs) covering areas of responsibility
* Monitor compliance and assist in the production of routine compliance metrics
* Any other duties or projects as requested by the Line Manager commensurate with the grade and level of responsibility for this role, for which the associate has the necessary experience and/or training
Qualifications:
University degree qualification or equivalent in Pharmacy, Life Sciences, Marketing or Business Management or a related field - desired
Skills:
Communication skills
Teamwork / team build
Results orientated
Customer focused
Extremely detailed focused
Rapport building skills
Computer literate
Please do let me know if this is something you would consider. Referrals are also rewarded.
L.Khan(a)realstaffing.com