4 months ago
Job title: Regulatory Affairs Associate Director, Global Labelling
A Biopharmaceutical company in Oxfordshire are seeking a Regulatory Affairs Associate Director, Global Labelling. Reporting directly into the Head of Global Labelling, this role will be responsible for both technical and operational support within Labelling across global markets.
- Manage quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
- Under the direction of the Head of Global Labelling, assist in implementing process improvements to increase the efficiency and effectiveness of the label review process
- Provide project management to the Labelling Team throughout the entire process, from the decision to update a CCDS/USPI/SPC through notification to stakeholders
- Lead the development of CCDS, package inserts and equivalents and their associated Patient Labelling Documents
- Support the Head of Global Labelling in providing development and guidance to Labelling Managers and Senior Labelling Managers.
- Proven experience in regulatory affairs with particular focus on labelling
- Experience associated with global product labelling regulations strongly desired
- Ability to review regulatory labelling documents for accuracy and adherence to regulatory requirements, noting deficiencies and inconsistencies
Salary and benefits:
A competitive salary, annual bonus and wider benefits package in on offer with this role
To apply for this position or hear further details then please contact Matt Thomas via firstname.lastname@example.org