Global Regulatory Affairs Manager
2 meses atrás
Join an international pharmaceutical company who is looking for a Global Regulatory Affairs Manager.
Your new company
Excellent opportunity to join an international pharmaceutical company who is looking for a Global Regulatory Affairs Manager - Drug Product.
Your new role
This professional will be responsible for processing and coordination of regulatory affairs, communication with authorities and other approval-related tasks within the quality organization for drug product manufacturing sites based in different countries in Europe.
**This professional is also responsible for**:
Preparation and processing of pharmaceutical quality documents for submission, processing of defect notices, amendments, extensions and maintenance of commercial approvals worldwide;
Act as Establishment Registration point of contact for FDA;
Coordination EMA SPOR database for the manufacturing sites;
Participates in customer audits and authority inspections;
Checks internal change control processes, changes in GMP documents and deviations for approval relevance.
What you'll need to succed
We are looking for a professional with Life Sciences degree, with experience a t least 5 years in pharmaceutical production, regulatory or quality assurance unit within the pharmaceutical industry. Advanced English skills is mandatory and Germany or French fluency is an asset. Experience in delivering client-focused solutions based on stakeholder needs, excellent listening and presentation skills are required.
What you'll get in return
This is an excellent opportunity to join an international pharmaceutical company that serves customers worldwide.
What you need to know
1030472
Salary according the role.
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