Description
Responsibilities
- Awareness of and adherence with Labelling requirements including, but not limited to, relevant internal and external legislation, regulations, standard operating procedures, guidance and templates etc.
- Review of proposed, or approved, PI texts for compliance with relevant mandated safety triggers, Brand Leader (or other Legal Basis Reference Product) and CMC data. As required, this includes locating and confirming the validity of such information.
- Maintaining Company Core Data Sheets and local labelling deviations
- Authoring of the SmPC, confirming compliance with mandated safety triggers, Brand Leader, CMC and relevant Labelling requirements.
- Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements.
- Supporting Regulatory Leads with responses to questions and requests for further information, which impact PI texts.
- Working with Global Product Safety and Risk Management – Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Labelling Committee for endorsement of recommendations.
- Support Brand Leader monitoring process
Qualifications
- BSc in Life sciences or related area.
- Minimum 2 years of Regulatory Affairs Labelling experience
- Knowledge of the regulatory pharmaceutical industry including labelling is desirable.
- Previous experience of Document Management System useful
- Excellent prioritization and time-management skills
- IT literate with proficiency in using word, excel, power point.
- Office acumen, good team player, multitasker, business focused.
