Labelling Consultant

Key People

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Job ID :

15204


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

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


Key Skills :

regulatory, labelling, leader, lead, regulatory, regulatory affairs, hertfordshire


Salary :

£30 - £33 per annum


Date Posted :

14 Aug, 2019



Company Name :

Key People


Location1 :

St. Albans




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

My client, a global Pharmaceutical company, is currently seeking a Regulatory Lead to join their team on an initial 12 month contract basis based in Hertfordshire.

Responsibilities:

*Authoring of the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC and relevant Labelling requirements.

*Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements.

*Review of proposed, or approved, PI texts for compliance with relevant mandated safety triggers, Brand Leader (or other Legal Basis Reference Product) and CMC data.

*Working with Global Product Safety and Risk Management - Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Labelling Committee for endorsement of recommendations.

*Awareness of and adherence with Labelling requirements including, but not limited to, relevant internal and external legislation, regulations, standard operating procedures, guidance and templates etc.

*As required, supporting Regulatory Leads with, but not limited to, responses to questions and requests for further information, which impact PI texts.

*As required, other Labelling activities such Brand Leader monitoring to support the business.


Experience Required:
*Proficiency in speaking, comprehending, reading and writing English.
*Knowledge of the regulatory pharmaceutical industry including labelling is desirable.
*Life science degree is desirable.
*BSc in Life sciences or related area.
*At least 24-months Regulatory Affairs experience for Senior Registration Officer and at least 12 months Regulatory Affairs experience for Registration Officer.
*Excellent prioritization and time-management skills.
*IT literate with proficiency in using word, excel, power point.
*Previous experience of Document Management System useful

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


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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