Senior Manager, North America Regulatory Liaison

About the role

This position is a hybrid role and will be located in Spring House, PA; Titusville, NJ; or Raritan, NJ. The Senior Manager, North America Regulatory Liaison will serve as a strategic regulatory leader, driving North America regulatory strategy and execution for assigned Immunology projects.

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., clinical protocols, study reports, summaries).
• Apply knowledge of regional and global regulatory frameworks, trends, and requirements across all phases of development.
• Lead the planning, preparation, and delivery of regulatory submissions (simple to complex) across the product lifecycle.
• Develop and maintain submission delivery timelines, content plans, and execution strategies.
• Author and/or critically review submission components, ensuring quality and compliance.
• Manage regulatory applications and associated procedures through Health Authority approvals.
• Serve as primary point of contact with Health Authorities (e.g., FDA).
• Lead and coordinate Health Authority interactions, including preparation of briefing materials and responses.
• Manage responses to regulatory queries and requests.
• Partner with global regulatory and cross-functional teams to align on submission and interaction plans.
• Lead or contribute to cross-functional submission teams to ensure timely and effective execution.
• Communicate clear, proactive status updates to stakeholders.
• Identify and drive process improvements, applying critical thinking and problem-solving skills.
• Demonstrate strategic thinking, including contingency planning aligned with business objectives.
• Influence decision-making across a matrixed organization.
• Represent the company externally with Health Authorities and industry partners, as appropriate.
• Build and leverage strategic relationships and networks.

Qualifications

• A minimum of a Bachelor’s degree in a scientific or technical discipline is required. Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline preferred.
• A minimum of 8 years of relevant regulatory experience with a Bachelor’s degree; a minimum of 6 years of relevant regulatory experience with a Master’s or PharmD degree; or a minimum of 4 years of relevant regulatory experience with a Ph.D. is required.
• 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.
• Experience in Immunology therapeutic area preferred.
• Experience in people management/coaching/mentoring is preferred.

Additional Scope

• May serve as Regional Regulatory Leader for assigned programs.

Required 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

Preferred Skills

• People Management/Coaching/Mentoring

Pay

The anticipated base pay range for this position is: $137,000.00 - $235,750.00