Regulatory Affairs Manager, Labelling

Key People

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Job ID :

12028


Company Type :

Staffing Firms


Industry :

Science and Research


Education Level :

Master of Science


Address 1 :

United Kingdom,Oxfordshire,Oxfordshire,


Key Skills :

regulatory affairs, labelling, PILs, smpcs, smpc, label, manager, senior manager, senior regulatory


Salary :

£55000 - £65000 per annum + bonus and excellent benefits


Date Posted :

28 Jun, 2018



Company Name :

Key People


Location1 :

Oxfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

My client, an established Biopharma based in Oxfordshire is currently searching for an experienced Senior Manager Regulatory Affairs Labeling to join their team based in Oxfordshire. Within this role you will be responsible for regulatory support (both technical and operational) in the area of product labelling. You will report to the Head of Global Labeling and you will be responsible for key functions including creating, updating and maintaining labeling documents throughout the product lifecycle, with primary focus on Company Core Data Sheets and products marketed globally.

Responsibilities:

-The candidate will help maintain controlled records for historical labeling changes, and communicate labeling changes to stakeholders at the time of implementation.
-Help to implement process improvement changes to increase the efficiency and effectiveness of the label review process.
-This position will interact cross-functionally with members of commercial, legal, safety, medical, and others.
-Maintain expertise regarding key labeling requirements worldwide and stay current with labeling guidelines and regulations as they pertain to the development/maintenance of labeling and advise key stakeholders on the application of these labeling principles.
-Maintain controlled records for historical, current, and ending labeling changes, and communicate labeling changes to stakeholders at the time of implementation.
-Manage quality control over entire labeling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
-Provide project management to the Labeling Team throughout the entire process, from the decision to update a CCDS/USPI/SPC through notification to stakeholders, to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements
-Responsible for proofreading and departmental QC work
-Lead the development of CCDS, package inserts and equivalents and their associated Patient Labeling Documents
-When developing new labels, research the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text, including contingency strategy development for negotiation with regulatory authorities.

Minimum Requirements:

-S/B.A. (or equivalent in industry related experience)
-Proven experience in regulatory affairs with particular focus on labelling
-Experience associated with global product labeling regulations strongly desired
-Strong judgment and decision making skills
-Excellent written and verbal communication skills
-Ability to review regulatory labeling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
-Must be able to work successfully within a team/partnership environment and as an individual contributor, with a high level of professionalism
-Ability to interact effectively with all levels/roles of project team members

For further details about this role, 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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