Global Labelling Lead - UK

Regulatory Affairs - Global Labelling Lead - Pharmaceutical Industry.

This is a 12 month freelance contract.

UK - Reading - Office Base once COVID restrictions are lifted.

Job Description

Our client, a Global CRO are searching for a Global Labelling Lead.

The end client is a highly reputable, globally renowned Pharmaceutical company. If you are a Regulatory professional in the Pharmaceutical sector, please read the below.

The Global Labelling Lead (GLL) has overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. This includes guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents.

The GLL provides project management to the Labelling Team throughout the entire process, from the decision to update a CDS/USPI/SPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements.

Responsibilities

• Utilize regulatory, labelling and project management expertise to oversee and support the development, review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labelling Documents.

Requirements;

- You must have a minimum of 7 years experience in Pharmaceutical Regulatory Labelling

- You MUST have USPI, SmPC, CCDS creation, review and maintenance experience.

- You must have either line management or project management experience within pharmaceutical Regulatory Affairs