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Regulatory Affairs CMC Manager (m/w)
Eingestellt von Progressive aus Düsseldorf
Projektbeschreibung
Regulatory CMC Manager (m/f)
Job description:
- Formulate, lead and drive regional and/or global CMC regulatory strategy for assigned development projects and/or marketed products with a focus on creativity and innovation
- Proactively provide strategic input and communicate critical topics in adequate and timely manner to interdisciplinary project teams and to appropriate management level.
- Drive CMC submission activities (planning, review, coordination, submission) for assigned projects/products. Make quality regulatory decisions as necessary, balancing risks and benefits.
- Represent Regulatory CMC in interdisciplinary regulatory and technical project teams.
- Establish and maintain a single point of contact with internal and external partners and customers for all communication on development projects and marketed products. Establish and maintain sound working relationships
Experience / Professional Requirements:
- Scientific degree in biotechnology, biochemistry, cell biology or equivalent
- At least 3-5 years of experience in Regulatory Affairs
- Excellent working knowledge/experience in regulatory submissions and approval processes for Biopharmaceuticals and ability to deal with complex CMC regulatory issues and requirements
- Strong background in biopharmaceutical development (e.g. cell culture, downstream processing, analytics)
- Proven track record in successfully leading/working in interdisciplinary teams, and of planning, coordinating and leading activities simultaneously on multiple projects.
- Strong interpersonal, organizational, communication, presentation, negotiation and problem solving skills.
- fluentcy in English (German language skills are a plus)
Interested??
Then apply now by sending me your CV in MS WORD format or use the online application form.
Projektdetails
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Einsatzort:
Frankfurt am Main, Deutschland
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Projektbeginn:
asap
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Projektdauer:
Keine Angabe
- Vertragsart:
-
Berufserfahrung:
Keine Angabe
Geforderte Qualifikationen
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Kategorie:
Sonstiges