At Regulatory Professionals, we understand that the international Landscape for Regulatory Operations is constantly evolving, and the need to be able to adapt to future changes.

We recruit for a wide range of jobs within regulatory submissions and regulatory publishing across Europe, including:

•    Regulatory Affairs Submissions Co-ordinator
•    Regulatory Affairs Publishing Associate
•    Regulatory Submissions Manager
•    Senior Regulatory Manager Publishing/Submission

Some of the requirements within the regulatory submission and publishing jobs that we recruit for, include:

•    Submitting an original IND, NDA or ANDA, an amendment or supplement
•    Submitting a variation to an existing application
•    Converting an existing application to eCTD format
•    ANDAs, 510Ks, DMFs, IMPDs
•    Annual Reports, Amendments, Orphan Drug Designation Requests, Clinical Study Reports, Investigator Brochures, Clinical Protocols, Case Report Forms, SOPs
•    Publishing activities included formatting, proofreading and correction of typographical and grammatical errors, insertion of appendix pieces into documents, scanning, clean-up of PDF files, QC of each publishing step as well as published product
•    Documents and dossiers for submission to clients and regulatory authorities, compilation, printing, print QC, page numbering, tab creation, assembly/binding, label creation and application
•    Packing for shipment to clients and/or regulatory authorities

To find out how we can help progress your regulatory career in regulatory submissions and publishing, contact us on +44(0)118 952 2797 or apply@regulatoryprofessionals.com.

Alternatively you can check our ‘Vacancies’ page for the current Regulatory Submission and Publishing Jobs.

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