Company: Regulatory Professionals
Closing Date: 20 Nov 16
Type: Full Time
Salary (£): On Application
Global Labelling Product Leader - Neuroscience\ Established Products. Duration: 12 Month Contract Rate: up to £55 per hour Location: Buckinghamshire Do you want to work for one of the largest Pharmaceutical Companies in the World?
Global Labelling Product Leader - Neuroscience\ Established Products
Duration: 12 Month Contract
Rate: up to £55 per hour
Do you want to work for one of the largest Pharmaceutical Companies in the World?
Do you have 3+ years labelling experience within Regulatory Affairs?
Have you previously updated a CCDS, prepared USPIs or EUPIs?
If so, then this role might be the one for you.
Regulatory Professionals are currently recruiting on behalf of one of the largest pharmaceutical innovators in the industry, seeking a Global Labelling Product Leader to support labelling activities and to ensure regulatory compliance through remediation activities.
Responsibilities will revolve around supporting product labelling activities as part of a Labelling Compliance Program and documenting deviations in accordance with the set deviations process.
The successful candidate will be expected to follow established processes to bring the labelling updates to fruition and manage labelling documents in a document management system.
The contractor will also be asked to lead Labelling Working Groups and Labelling Committees for consensus and agreement on labelling revisions, assist in issuing CCDS updates, preparing USPIs and/or EUPIs for submissions, and assist with responses to health authority questions and queries.
*4+ years Regulatory Affairs Labelling Experience
*Product labelling experience should include authoring text for inclusion in product labelling (CCDS, EUPI, USPI), including drafting text based on scientific source data, supporting rationale, and regulatory requirements, standards and templates, and liaison with subject matter experts and regulatory professionals.
*Advanced Microsoft Word and Excel skills and experience in Documentum-based document management system.
*Excellent project management, verbal and written communication skills.
*Minimum of Bachelor's degree in a scientific discipline or equivalent.
*Advanced degree (MS, PharmD, PhD, or MD) highly desired.
This is a brilliant opportunity to be part of a major project working for a well renowned pharmaceutical innovator.
Opportunities to work for this client on a contract basis are not a common occurrence.
Keywords: Regulatory Affairs Project Manager, Regulatory Affairs Senior Officer, Regulatory Affairs Officer, Regulatory Affairs Labelling, Labelling, Labeling, CCDS, SmPC, USPI, EUPI, PILs, PSUR, Buckinghamshire, Berkshire, Hertfordshire, Middlesex,
3rd floor 33 Blagrave Street Reading
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