Overview

Reference Number: JO-2106-470004
Global Regulatory Lead
Rate: Negotiable
Job Type: Permanent
Location: Chicago

US Global Regulatory Lead

Chicago / Milwaukee or Remote based

Permanent

A global pharmaceutical company specializing in centralized procedure applications have created an exciting new position for a US Global Regulatory Lead.

As the Global Regulatory Lead you will work within the companys product development team, contributing to activities from pre-clinical through to clinical studies and initial registration.

Collaborating with cross-functional global project teams for new product introductions providing strategic advice.

Key Duties Include:

– Developing innovative global regulatory strategies for assigned projects.

– Communicating with key health authorities & lead meetings with authorities

– Lead marketing authorizations for US and EU and support other global markets.

– Reviewing and contributing to submission during development

– Ensuring successful NDA and MAA filings and guide cross

– Functional global project teams for the content and preparation of submissions.

Candidate Requirements:

– Bachelors degree (or equivalent) in a scientific discipline

– 7+ years experience working within regulatory affairs, must have recent experience submitting applications via centralized procedure.

– Expertise of global regulatory affairs from the pharmaceutical or healthcare industry with a track record in key strategic roles.

– Proven experience of global project management and world-wide regulatory authority interaction.

– A keen interest in scientific advances that impact healthcare product development and regulations

– Experience of working effectively across multinational/cultural environments.

– Previous experience within radiopharmaceutical products would be a major advantage.

To be considered for this opportunity or to request further information please contact Gary.Crawley@cpl.com.