Regulatory Affairs Project Manager

2 days ago

Reading, United Kingdom Pharma Partners Recruitment Ltd Full time

Job Description Job title: Regulatory Affairs Project Manager – UK/IE A Top 10 Pharmaceutical business in Berkshire are seeking a Regulatory Affairs Project Manager.
This is a UK/IE affiliate role and will work across an Oncology portfolio.
Responsibilities: Serves as Health Authority liaison and interfaces with Health Authorities.
Lifecycle management of applicable products and management of Clinical Trial activities with the MHRA.
Reviews promotional, non-promotional and training materials, as applicable, and ensure the materials are compliant with local regulations and internal policies and procedures.
Ensures submission and content of new Marketing Authorisations, variations and other regulatory submissions, including label, artwork and local prescribing information are made in accordance with appropriate timings and requirements and maintain an appropriate tracking of the process as applicable.
Requirements: Life Sciences Degree or equivalent experience Varied experience within Regulatory Affairs, including commercial affiliate awareness and clinical trial knowledge Experience of reviewing material against the ABPI Code of Practice Therapy experience within Oncology would be desirable

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