Assistenz Regulatory Affairs (m/w/d) Pharma
at
Heidrun Jrgens Personaldienstleistungen
Germany, Berlin, Germany
-
Full Time
Start Date
Immediate
Expiry Date
07 Dec, 26
Salary
0.0
Posted On
08 Sep, 26
Experience
0 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Industry
Pharmaceutical Manufacturing
Description
Supporting Regulatory Affairs Managers in compiling regulatory documents in eCTD format
Support with national and international (worldwide) approval procedures from the submission of the application and documents to the granting of market approval.
Support for international admission procedures
Creation and maintenance of registration dossiers in the eCTD Manager
Creation of product information texts as well as the electronic application form for submissions in EU and US procedures.
Support in reviewing and compiling documents for the renewal, extension and updating of approvals (national and international)
Archiving of registration documents (e.g. in the eCTD Manager)
Knowledge and application of current legislative and regulatory requirements in the field of eRA
Collaboration with external partners and customers as well as within the company
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