Global Regulatory Liaison: Oncology & Immunology

HireLifeScience; Rahway (NJ); Hybrid; USD 173,000 - 273,000; Full time

Job summary

HireLifeScience seeks a Global Regulatory Liaison to develop and implement worldwide regulatory strategy for oncology, immunology and devices projects. You will oversee global regulatory activities, coordinate submissions, and act as the primary contact for regulatory affairs across development programs.

Ideal candidates have extensive experience with regulatory filings and a proven ability to lead cross-functional teams in a fast-paced, global environment.

Qualifications

• Clinical trial oversight and regulatory strategy development across multiple indications.
• Experience interacting with FDA/EMA or other health authorities preferred.
• Ability to lead regulatory teams and coordinate global submissions.
• Strong written and verbal communication for regulatory documentation.

Responsibilities

• Develop worldwide regulatory strategy to optimize label and time-to-approval for multiple indications.
• Advise Product Development Teams on regulatory issues across drug life cycle.
• Lead Global Regulatory Team to coordinate cross-functional support for programs.
• Review and approve local/global submission protocols for regulatory approvals.
• Coordinate interactions with regulatory agencies and subsidiaries internationally.
• Lead advisory committee preparations with cross-functional teams.
• Ensure alignment of regulatory submissions with global marketing applications and study reports.
• Provide regulatory input within internal committees and product development teams.
• Conduct IND/CSA content review and clearance for clinical trials.

Skills

Clinical Research

Cross-Functional Teamwork

Drug Development

Global Regulatory

Oncology

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Filings

Regulatory Management

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Planning

Strategic Thinking

Education

B.S. Degree in biological sciences or related discipline

M.S. in a relevant field

PhD with relevant experience

M.D. with relevant experience

Job description

HireLifeScience seeks a Global Regulatory Liaison to develop and implement worldwide regulatory strategy for oncology, immunology and devices projects. You will oversee global regulatory activities, coordinate submissions, and act as the primary contact for regulatory affairs across development programs.

Ideal candidates have extensive experience with regulatory filings and a proven ability to lead cross-functional teams in a fast-paced, global environment.