Junior Reg. CMC Manager (m/f)

REFERENZNUMMER:

303855/11

IHRE AUFGABEN:

-As early as possible, identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
-Author high-quality CMC regulatory documentation for health authority submission of assigned development projects and/or marketed products in biologics, applying CMC global regulatory strategies and assuring technical congruency
-Ensure that regulatory documentation meets health authority guidelines and requirements
-Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and to appropriate management level in Reg. CMC, DRA, TechOps and TRD as appropriate
-Contribute to defining the global regulatory strategy, identifying the critical issues and sharing lessons learned
-Facilitate consistency within the CMC regulatory documentation by sharing experience and/or contributing to template maintenance
-Contribute to the preparation of CMC dossier risk analyses (SWOTS), contingency plans and lessons learned on major submissions
-Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
-Establish and maintain sound working relationships with partners and customers

IHRE QUALIFIKATIONEN:

-Degree in Science, preferably in Biotechnology, Biochemistry, Biology, Cell Biology or equivalent
-Experience in regulatory preferred, and/or experience in biologic pharmaceuticals
-Working knowledge/experience in regulatory submission and approval processes for New Biological Entities (NBE) and product life cycle management, and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements
-Demonstrated track record of successfully working in interdisciplinary teams, and of planning, coordinating and leading activities simultaneously on multiple projects
-Demonstrated ability for risk assessment and mitigation
-Strong interpersonal, communication, negotiation and problem solving skills
-Fluency in English

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager