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Manager Regulatory Affairs CMC Pharmaceutical Development at BIONORICA SE

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

Skills

Industry

Pharmaceutical Manufacturing

Description

Responsibility for the creation, review, updating and strategic development of regulatory CMC documentation for national and international approval procedures, with a focus on CTD modules 2.3 and 3.
Coordination and management of the creation of regulatory documents and data packages in close cooperation with specialist departments such as Regulatory Affairs, Quality Assurance, Production, Analytics and Development
Independent preparation, consolidation and quality control of regulatory dossiers including eCTD submissions, variations, renewals
Technical assessment of regulatory requirements and development of approval strategies in the field of Chemistry, Manufacturing and Controls (CMC)
Responsibility for handling complex national and international official inquiries and for preparing well-founded responses and scientific-regulatory justifications.
Monitoring of national and international 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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Responsibilities