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Regulatory Affairs Manager CMC (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Support

Projektbeschreibung

REFERENZNUMMER:

341173/11

IHRE AUFGABEN:

-Prepare and support DMFs and NDA/MAA/BLA for customers (for small molecules, peptides, ACDs and/or microbial biotech products)
-Support review, writing and/or approval of site specific regulatory documents
-Provide regulatory support and advice for internal and external customers in line with defined Regulatory plans and in response to ad-hoc questions
-Keep documented regulatory project plans in line with best practice recommendations
-Update functional leads and maintain transparency of information across regulatory functions
-Facilitate and support the implementation of regulatory information management systems within the company and the creation of corresponding business processes within the RA team

IHRE QUALIFIKATIONEN:

-Life Sciences degree (i.e. chemistry, biology)
-Profound experience in the pharmaceutical industry in regulatory affairs, especially CMC
-Understanding of EU and US regulatory requirements for API
-Experience in working with regulatory authorities
-Experience in preparing and authoring Module 3 CTD i.e. for IND/IMPD, NDA/MAA
-Fluency in English, further communication skills in German or French are of advantage

WEITERE QUALIFIKATIONEN:

Regulatory affairs manager

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 MM+

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    Sonstiges

  • Skills:

    support

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland