CMC Consultant (m/w/d)

Beschreibung

Gesucht: CMC Consultant (m/w/d) in Hessen

Ihre Aufgaben als CMC Consultant (m/w/d)

• Assist senior colleagues for the global CMC strategy and plan for dossiers related to the assigned projects/products. Examples for these dossier comprise clinical trial applications, answers to Health Authority queries, life cycle management submissions, marketing authorization applications, briefing documentation for Health Authority interactions.
• Responsible to provide country specific CMC regulatory requirements for dossier strategies and plans in close collaboration with other GRA functions. This includes assessment of Change Control Proposals under supervision for their regulatory impact worldwide to ensure that for each change control proposal, the regulatory implications have been considered.
• Review study protocols and reports, as well as other relevant technical documents intended for the product documentation platform or for local submission to confirm alignment of the report conclusions with the CMC Dossier Strategy and Plan.
  - Support to confirm alignment between CMC dossier strategy and CMC regulatory documents before approval regarding fit to strategy, gaps, issues, risks and mitigation measures (within Dossier Generation Team)
  - Accountable to track submission and approval status to ensure regulatory compliance for all CMC dossier submissions worldwide
• Global Regulatory Affairs CMC coordination - Support development and execute initiatives to ensure regulatory compliance - as required

Ihr Profil

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  Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)
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  Work Experience: Minimum of 1-2 years of pharmaceutical industry experience
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  Ability to understand and support the development of regulatory strategies and dossiers
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  Experience in preparation and management of regulatory documentation, or variations
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  Experience with life-cycle management activities would be an asset)
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  Practical experience in one of the following area for biotech molecules: manufacturing process development, transfers, validation or analytical development and quality management
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  Knowledge of global pharmaceutical legislation
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  Excellent written and spoken communication skills in English (knowledge of other European languages is an asset such as German)
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  Good interpersonal skills and flexible mindset

Rahmendaten

• Projektstart: 01.07.2019
• Projektdauer: 12 Monate
• Einsatzort: Hessen
• Remote-Anteil: 20%

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