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Project Lead Regulatory Affairs

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W3Global Inc

2021-12-04 01:00:05

Job location London, Greater London, United Kingdom

Job type: fulltime

Job industry: Legal

Job description

Directs and coordinates activities concerned with the submission and approval products to government regulatory agencies.

Provides guidance to project team members regarding regulatory compliance issues.

Oversees the preparation and maintenance of regulatory submissions and files.

Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.

Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.

Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.

Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.

Works with team members to determine regulatory impact of manufacturing changes on products, prepare and submit applications, and the assess the impact product changes have on the status of regulatory licenses.

Interprets regulatory requirements and determines strategies to obtain clearances and approvals

Independently makes decisions regarding work processes or operational plans and schedules

Ensures organization compliance with all applicable regulations and policies

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