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| Company: |
projects recruters |
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| Job Title: |
Pharmaceuitical/Biologic Consultant's |
| Employment Category: |
Production |
| Job Location: |
Mexico |
| Job Reference Number: |
1 |
| Job Description: |
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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Skills Required:: |
Good verbal and written skills are required. |
Language Requirements: |
English-Very GoodSpanish-Very Good
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| Employment Type: |
Contract
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| Yearly Salary: |
Unspecified
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| Posting Date: |
Mar 05 2008 |
| Education level required: |
Masters
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| Experience in years: |
5 to 7 Years |
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