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| Empresa: |
projects recruters |
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| Título del Empleo: |
Pharmaceuitical/Biologic Consultant's |
| Categoría de Trabajo: |
Producción |
| Localización del Empleo: |
México |
| Número de Referencia de Empleo: |
1 |
| Descipción del Empleo: |
Seeking 2 tiers of consultants-junior and senior with the following experience:
Regulatory affairs, regulatory compliance, submission. Gap analysis, product conformance review
FDA experience:
Pharmaceutical Current Good Manufacturing Practices (cGMP)
Marketing Authorization Application (MAA)
Changes Being Effected (CBE) supplements
a new drug application (NDA)
an abbreviated new drug application (ANDA)
a biologics license application (BLA)
Chemistry Manufacturing and Controls (CMC)
Country specific requirements
EU GMP, European Medicines Agency (EMEA)
Other applicable pharmaceutical regulatory requirements
Professional associations: ISPE, PDA
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| Habilidades: |
Good verbal and written skills are required. |
| Requerimientos de Idioma: |
Inglés-AvanzadoEspañol-Avanzado
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| Tipo de Empleo: |
Contrato
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| Sueldo: |
No especificado
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| Día de envío: |
05 mar 2008 |
| Nivel de Estudio: |
Master
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| Experiencia (Años): |
5 o 7 años |
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