Senior Manager, North America Regulatory Liaison

$137k - $235.75k

Johnson & Johnson

Johnson & Johnson seeks a Senior Manager for North America Regulatory Liaison within Innovative Medicine, responsible for developing regulatory strategy and executing submissions for immunology projects. This hybrid role, based in Pennsylvania or New Jersey, requires strategic leadership to guide product development pathways and manage Health Authority interactions.

Responsibilities

Develop and execute North America regulatory strategy for assigned immunology projects
Lead planning, preparation, and delivery of regulatory submissions across product lifecycle
Serve as primary point of contact and lead interactions with FDA and other Health Authorities
Partner with global and cross-functional teams to align submission and interaction plans
Identify process improvements and drive operational excellence across regulatory functions

Requirements

Bachelor's degree in scientific or technical discipline; advanced degree (Master's, PharmD, Ph.D.) preferred
Minimum 8 years regulatory experience with Bachelor's; 6 years with Master's/PharmD; 4 years with Ph.D.
Pharmaceutical, biotech, or OTC industry experience required
Expert knowledge of clinical drug development and regulatory pathways
Demonstrated experience managing lifecycle submissions (IND, NDA, CTA, MAA)
Proven track record of FDA and global Health Authority interactions
Immunology therapeutic area experience preferred

Apply

Vacancy posted 23 days ago

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