Regulatory writers are required to prepare high quality documentation for regulatory submissions in order to help avoid delays in the regulatory approval process.
Regulatory document writing / labelling jobs include writing for:
• Investigational Medicinal Product Dossiers (IMPD)
• Investigator Brochures (IBs)
• Common Technical Document (CTD) – Chemistry, Manufacturing and Controls (CMC), non-clinical and clinical documents – whether for NCEs or approved products
• Clinical Study Reports (CSRs)
• Periodic Safety Update Reports (PSURs)
• Company Core Safety Information/ Company Core Data Sheets (CCSI/CCDS)
• Reclassification applications (POM to P, or P to GSL)
• Paediatric Use Marketing Authorisations (PUMAs)
• Risk Management Plans (RMPs)
• Labelling regulatory documents – Summary of Product Characteristics (SmPC)
• Integrated summaries of efficacy and safety
Our specialist regulatory team recruit for a variety of regulatory writing vacancies across Europe, ensuring that we match the right candidate with the right job for their career progression. Some of the jobs vacancies within regulatory writing / labelling that we recruit for include:
• Regulatory Labelling Officer
• Senior Regulatory Affairs Medical Writing Associate
• Senior Medical Writing Manager
• Medical Writing Associate Director
• Regulatory Labelling Director
To find out how Regulatory Professionals can help your regulatory writing and labelling job search, contact our specialist team on +44(0)118 952 2797, or email us at apply@regulatoryprofessionals.com
Alternatively you can check our ‘Vacancies’ page for the current Regulatory Writing and Labelling Job Vacancies
