Regulatory Affairs Manager CMC

Regulatory Affairs Manager CMC

Wörwag Pharma

Böblingen, Germany

These tasks await you

• Ensuring the quality of documentation for marketing authorisations in terms of content and regulatory requirements, with a focus on pharmaceutical quality (Module 3, Module 2.3)
• Independent preparation/authoring and updating of CMC documentation (Module 3 and Module 2.3) of international marketing authorisation dossiers/core dossiers
• Timely provision of CMC relevant documentation to RA-M1 managers for global new submissions and renewals, as well as for quality relevant variations (national, European harmonized, other harmonized and global)
• Timely support in response to complaints/deficiencies about pharmaceutical quality
• Preparation of administrative approval documents, as long as they relate to the content of Module 3
• Regulatory assessment of module 3 and module 2.3 taking into account the manufacturing documentation and current guidelines in the process of change evaluation
• Regulatory support of cross-departmental projects (e.g. in the case of changes in production, changes in manufacturer, technical transfer, changes in the composition of medicinal products) for the European and global markets
• Consultation on approval-related issues within the company and from the authorities
• Regulatory assessment of ASMFs
• Training of regulatory apprentices in terms of regulatory requirements and working practices
• Development and optimization of internal regulatory processes

What you bring with you

• Degree in chemistry, pharmacy or a comparable natural science
• At least 2 years of professional experience in regulatory affairs
• Very good knowledge of the legal regulations concerning drug registration
• Very good knowledge of the technical and content requirements for authoring of a marketing authorisation dossier
• Readiness to cooperate within the Regulatory Affairs Department (within CMC team and with other teams), with in-house departments (Development, Quality, Purchasing, GMA) and contract manufacturers, as well as with external contractors
• Independent, structured and integrative work, assertiveness, ability to deal with conflicts, resilience, reliability
• Very good PC knowledge (MS-Office)
• Very good knowledge of English
• Good knowledge of process and project management

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