Regulatory Affair Specialist
Teva Pharmaceuticals - Puerto Rico

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Responsibilities:
MAJOR DUTIES AND RESPONSIBILITIES

New DMFs preparation
DMF Annual Report preparation
DMF Amendment preparation
Product Transfer Equivalency Report preparation
“Drug Product Listing” Form maintenance
“Registration of Drug Establishment Form” maintenance”
Response to DMF Deficiency Letters
Coordination of product sampling for customers
Preparation of documents to accompany samples and shipment
Provide customers with documentation requested such as DMFs DMFs open part , C OAs etc
Procures resolution of issues and satisfaction by evaluation and clarification of requirements before delivering responses and services to internal and external customers

OTHER REQUIREMENTS

Work over- time as required to keep area updated.
Comply with Good Manufacturing practices
Comply with safety rules and behavior rules established by API Industries.
Assists in the customer service activities as required
Able to provide analytical and technical judgment related to the Regulatory Affairs matters.

Qualifications:
Bachelor Degree in Science, preferable in Chemistry (or related experience).
Five years of experience in pharmaceutical industries, at least three doing a similar position.
Considerable knowledge of the principles, practices and current Trends in the relevant QA Area.
Good verbal and written communication skills in Spanish and English.
Knowledge of the Pharmaceutical Industry practices and procedures. The incumbent must also be familiar with the regulations of FDA, EDQM, EPA, OSHA
Computer literate (word, excel, power point)

Teva Pharmaceuticals - 17 months ago - save job - block
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When the pharmacist asks you if a generic equivalent is acceptable, Teva hopes you'll say "yes." Teva Pharmaceuticals USA,...