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| Firma: |
Kelly services (Suisse) SA |
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| Job-Titel: |
Senior CMC Regulatory Consultant |
| Job Kategorie: |
Pharma/Pharmazeutisch |
| Arbeitsort: |
der Schweiz |
| Stellen-Beschreibung: |
Job description:
Assist with the preparation and review of CMC sections to support US and EU regulatory submissions (IND, IMPD, BLA, MAA). In particular you will be involved in CMC risk assessments, preparation of Briefing package for Scientific Advice meetings, CMC development plans from the scientific concept to the production of pre-clinical and clinical material. You will also provide input on the identification of potential challenges (technical as well as regulatory) and solutions, and will contribute to the design of CMC strategies and liaise with the pre-clinical and clinical teams to design the appropriate regulatory pathway.
You will also assist with selection of CMOs (Audit and evaluation of manufacturers/CMO in terms of quality and cGMPs to provide input on stage-specific CMC regulatory requirements and recommendations for preclinical, phase I/II/III), help coordinating activities and communication between suppliers and client to follow up with the preparation of clinical material.
Evaluate CMC changes during clinical development and assess impact on CMC regulatory strategy; assist with providing CMC regulatory guidance to bridge changes with the clinic.
Contribute to the development of comparability, validation, and stability protocols, drug substance and drug product specifications, and raw material specifications.
Maintain up-to-date knowledge of the pharmacopoeia standards and EU and US regulations and guidelines related to CMC.
Knowledge of Viral Safety requirements and GMO regulations will be a plus. We are looking for a highly motivated and flexible person willing to be involved with different types of products including drugs, biologics and ATMPs. You are fluent in English.
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| Kenntnisse erforderlich: |
Training:
Chemist or biochemist or biologist with PhD, Master or Pharmacist diploma
Experience:
3 to 5 years in the industry with experience in technical aspects of Drug Development (Process Development, Method Development, Validation, Technical Transfer, Quality Control). Ideally experienced with Biologic/ATMP products and drug products. Good knowledge of the evolving regulatory environment in terms of CMC, quality, quality by design and science based development strategies. Experience with Technology Transfer and associated dossier amendments and variations. Experience with Project Management is required. |
Sprachkenntnisse: |
Englisch-Sehr GutFranzösisch-Gering |
| Beschäftigungsart: |
Vollzeit |
| Jahresgehalt: |
Keine Angabe |
| Eintragsdatum: |
2009-10-09 |
| Grad der Ausbildung: |
Master |
| Ihre Erfahrung in Jahren: |
3 to 5 Years |
| Firma: |
Kelly services (Suisse) SA |
| Kontakt-Name: |
Kelly Scientific Resources |
| Kontakt-Telefon: |
0041 22 737 12 01 |
| Kontakt -Fax: |
0041 22 737 12 13 |
| Bevorzugte Kontaktmethode: |
E-mail |
| Preferred Language of Resume/Application: |
French |
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