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Global Regulatory Lead - Biotech (Remote USA)
Remote / Online - Candidates ideally in
Toms River, Ocean County, New Jersey, 08757, USA
Listed on 2026-08-05
Toms River, Ocean County, New Jersey, 08757, USA
Listing for:
Outlook Therapeutics, Inc.
Remote/Work from Home
position Listed on 2026-08-05
Job specializations:
-
Business
Regulatory Compliance Specialist
Job Description & How to Apply Below
Outlook Therapeutics, Inc. is seeking an experienced Regulatory Affairs leader to own global filings and submissions for the US, EU, UK, and expansion markets. You will collaborate with FDA, EMA, MHRA, and in-country teams to ensure timely, compliant filings from CTAs to post-approval variations.
The role requires leading cross-functional teams, partnering with Clinical, CMC, Quality, and Manufacturing, and mentoring junior staff while supporting a commercial launch mindset.
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