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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
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
Geforderte Qualifikationen
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Kategorie:
Sonstiges