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Regulatory Specialist API (m/f)
Eingestellt von Hays aus Mannheim, Universitätsstadt
Gesuchte Skills: Natural, Support
Projektbeschreibung
REFERENZNUMMER:
321596/11
IHRE AUFGABEN:
-Ensure regulatory filing compliance as a basis to support the business for API production through developing and aligning regulatory filing strategies
-Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions: Coordination and preparation for new submissions, regular updates, variations and renewals
-Preparation and submission of Open Parts, Letter of Access, TSE Statement, Kosher/Halal Statement, Allergens Statement, Melamin free Statement, Latex free Statement, etc.) as well as the regulatory assessments of Change Requests and major non conformances
IHRE QUALIFIKATIONEN:
-A university degree in the field of natural sciences relevant to the task in question and to a solid understanding of the relevant chemistry
-Solid experience, working in regulatory affairs within the pharmaceutical industry and outstanding knowledge of the respective, regulatory environment for APIs ( CMC )
-Great German and English Skills in both verbal and written form as well as great interpersonal and team - player attributes
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
321596/11
IHRE AUFGABEN:
-Ensure regulatory filing compliance as a basis to support the business for API production through developing and aligning regulatory filing strategies
-Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions: Coordination and preparation for new submissions, regular updates, variations and renewals
-Preparation and submission of Open Parts, Letter of Access, TSE Statement, Kosher/Halal Statement, Allergens Statement, Melamin free Statement, Latex free Statement, etc.) as well as the regulatory assessments of Change Requests and major non conformances
IHRE QUALIFIKATIONEN:
-A university degree in the field of natural sciences relevant to the task in question and to a solid understanding of the relevant chemistry
-Solid experience, working in regulatory affairs within the pharmaceutical industry and outstanding knowledge of the respective, regulatory environment for APIs ( CMC )
-Great German and English Skills in both verbal and written form as well as great interpersonal and team - player attributes
WEITERE QUALIFIKATIONEN:
Regulatory affairs manager
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges