about 1 month ago
Job title: Regulatory Affairs Manager, Labelling
A Biopharmaceutical company in Oxfordshire are seeking a Regulatory Affairs Manager, Labelling to join their Operations team. This role will have responsibility for preparing labelling documents for submission and implementation globally.
- Manage quality control over entire labelling process and management of revisions, including assigning/tracking projects, workflow execution, and issue resolution
- Assist in implementing process improvements to increase the efficiency and effectiveness of the label review process
- Responsible for proofreading and departmental QC work, including during the Linguistic Review stages for EU language translations.
- Participate in the maintenance of Labelling documents with regard to CMC and technical changes in alignment with requirements and in support of the Labelling content leads.
- Proven experience in regulatory affairs with particular focus on labelling
- Experience associated with global product labelling regulations strongly desired
- B.S/B.A. (or equivalent in industry related experience)
- 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