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.
