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Regulatory Affairs CMC Manager (m/w)

Eingestellt von Progressive aus Düsseldorf

Projektbeschreibung

A successful pharmaCeutical company located in thze Rhine-Main area is seeking an experienced candidate for a full time permanent position:

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

  • Einsatzort:

    Frankfurt am Main, Deutschland

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Permanent

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

Progressive

  • Straße:

    Bleichstrasse 8-10

  • Ort:

    40211 Düsseldorf, Deutschland