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

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