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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

Projektdetails

  • Einsatzort:

    Zürich, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    5 MM+

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland