Regulatory Affairs Quality
at
Akkodis Germany Tech Experts GmbH
Berlin, Berlin, Germany
-
Full Time
Start Date
Immediate
Expiry Date
08 Jan, 27
Salary
54000.0
Posted On
10 Oct, 26
Experience
2 year(s) or above
Remote Job
Yes
Telecommute
Yes
Sponsor Visa
No
Skills
Industry
Pharmaceutical Manufacturing
Description
Responsibility for the creation, review, updating and strategic development of regulatory CMC documentation for national and international approval procedures, in particular CTD modules 2.3 and 3.
Coordination of the creation of regulatory documents and data packages in close collaboration with Regulatory Affairs, QA, Production, Analytics and Development
Independent preparation, consolidation and quality control of regulatory dossiers including eCTD submissions, variations and renewals
Assessment of regulatory requirements and development of approval strategies in the field of Chemistry, Manufacturing and Controls (CMC)
Handling complex national and international government inquiries and preparing well-founded responses and scientific-regulatory justifications.
Monitoring of regulatory developments and assessment of the impact on existing approvals and ongoing projects
Leading and participating in projects to optimize regulatory processes, documentation standards, data governance and eCTD compliance
Providing expert advice to internal stakeholders on regulatory and CMC-related issues, as well as support during inspections and audits.
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