Senior NA Regulatory Liaison Lead (Hybrid)

Biopharma Asia; Pennsylvania; Hybrid; USD 140,000 - 242,000; Full time

Job summary

Johnson & Johnson is seeking a Senior Manager, North America Regulatory Liaison, a hybrid role located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Lead NA regulatory strategy for Immunology programs and drive end-to-end submissions with cross-functional teams.

You will interact with FDA and Health Authorities, shape development plans, and influence key regulatory decisions while balancing risk and opportunity across the product lifecycle.

Qualifications

• Bachelor’s degree in a scientific or technical discipline required.
• Advanced degree (Master’s, PharmD, or Ph.D.) preferred.
• Experience in pharmaceutical, biotech, or OTC industry is required.
• Strong knowledge of clinical drug development and regulatory pathways is required.
• Experience managing lifecycle submissions (e.g., IND, NDA, CTA, MAA) is required.
• Demonstrated experience preparing, reviewing, and delivering regulatory documentation is required.
• Proven track record interacting with FDA and other global Health Authorities is required.

Responsibilities

• Contribute to and help shape regulatory submission strategies, identifying risks, mitigation plans, and opportunities.
• Provide strategic regulatory input into key development documents (e.g., protocols, study reports, summaries).
• Apply knowledge of regional and global regulatory frameworks across all development phases.
• Lead planning, preparation, and delivery of regulatory submissions across the product lifecycle.
• Develop and maintain submission delivery timelines and execution strategies.
• Author and review submission components ensuring quality and compliance.
• Represent the company with Health Authorities and coordinate interactions.

Skills

Analytical Reasoning

Business Writing

Compliance Risk

Fact-Based Decision Making

Industry Analysis

Legal Support

Mentorship

Organizing

Product Licensing

Public Policies

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Risk Assessments

Strategic Thinking

Technical Credibility

Education

Bachelor’s degree in a scientific or technical discipline

Advanced degree (Master’s, PharmD, Ph.D.) preferred

Job description

Johnson & Johnson is seeking a Senior Manager, North America Regulatory Liaison, a hybrid role located in Spring House, PA; Titusville, NJ; or Raritan, NJ. Lead NA regulatory strategy for Immunology programs and drive end-to-end submissions with cross-functional teams.

You will interact with FDA and Health Authorities, shape development plans, and influence key regulatory decisions while balancing risk and opportunity across the product lifecycle.