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Regulatory Engineer
Ref No.: 18-56884
Location: West Chester, Pennsylvania
Position Type:Contract
Start Date: 08/08/2018
1. Ensure compliance to local regulations and company policies.
2. Implement NPI & develop the regulatory submission plan. Support data analysis, mapping and migration activities from legacy systems
3. Oversee preparation and review registration documents to ensure the submissions meet appropriate standard and content requirement.
4. Interact with regulatory agency actively to expedite approval of pending application and to resolve regulatory matters.
5. Provide regulatory affairs support during internal & external audit.
6. Maintain up-to-date knowledge of local regulation & company policies.
7. Work within cross-functional project teams including R&D, Quality Assurance, Manufacturing and Medical Affairs for obtaining necessary documents.