Reference Number: JO-2106-470004
Global Regulatory Lead
Job Type: Permanent
US Global Regulatory Lead
Chicago / Milwaukee or Remote based
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.
– 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.