- Responsibilities and Accountabilities
The role is accountable for:
• the authoring, development and maintenance of the EU SmPC.
• leading cross-functional teams in the development and maintenance of the EU SmPC.
• the generation of responses to European Medicines Agency questions related to prescriber and patient information.
• the role may include authoring, development and maintenance of the Global Product Information (Global/Core datasheet).
This role requires prior relevant experience and may include:
• Management of the development and maintenance of the EU Summary of Product Characteristics (EU SmPC) through the early product lifecycle.
• Authoring responses to labelling questions from regulatory agencies.
• Management of the Global PI for marketed products, including presentation of items at Global Labelling Committees.
• Active membership in the Regulatory Matrix Team and submission writing process
• Awareness and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information.
• Supporting Local Operating Companies during implementation of Global PI wording.
• Authoring relevant sections of the periodic safety reports.
• Participation in other projects and activities, such as contributing to the implementation of changes to processes within GRA Labelling.
• Participation in mandatory training and completion of the training records.
Experience, Skills and Specialised Knowledge Required
• ****MUST HAVE direct EU SMPC Labeling experience*****
• Life sciences degree (Pharmacy or healthcare-related degree preferred), PhD or equivalent relevant experience.
• Relevant experience includes regulatory affairs with preference for prior labeling experience.
• Regulatory knowledge with preference for understanding pharmaceutical regulations and guidances related to product information.
• Excellent Scientific Regulatory Writing – the ability to produce written regulatory scientific communications with clarity, accuracy and rigor.
• Data analysis skills –understanding of biostatistics, clinical trial design, and clinical therapeutics
SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.
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