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Head of Regulatory Affairs at best of human GmbH

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

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

How To Apply:

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Responsibilities