Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases

Job Description

Regulatory Affairs Headquarters Principal Scientist is responsible for the development and implementation of global regulatory strategy for their assigned projects in the Vaccines and Infectious Disease therapeutic area.

• Serve as the single, accountable global regulatory point of contact for assigned products within Global Regulatory Affairs and Clinical Safety and to external organizations.
• Develop worldwide regulatory strategy to optimize label and obtain the shortest approval timelines for multiple indications simultaneously.
• Provide expert regulatory advice to Product Development Teams and subsidiaries throughout the product life cycle.
• Lead the Global Regulatory Team, coordinating cross‑functional regulatory support for development programs and marketed products.
• Represent the company with external organizations and regulatory agencies, chair meetings with the FDA, and prepare teams for FDA interactions.
• Lead cross‑functional efforts to prepare for advisory committees and, when required, speak at those committees.
• Coordinate interactions with foreign agencies and subsidiary registration departments to support regulatory strategy across multiple regions.
• Review and approve worldwide marketing applications, clinical study reports, protocols, and investigator brochures before release.
• Represent Global Regulatory Affairs within internal committees to provide regulatory advice and approval per committee charters.
• Conduct initial Investigational New Drug application and Clinical Study Agreement reviews to facilitate regulatory approval for clinical trials.
• Participate in regulatory due diligence for licensing candidates and collaborate with business development partners.

USA – Pennsylvania – North Wales – Upper Gwynedd

Additional Locations: USA – New Jersey – Rahway; USA – Pennsylvania – Philadelphia – We Work

10%

• M.D., Ph.D., or other related doctoral degree in biological science, chemistry, or a related discipline; a master’s degree with substantial regulatory experience may also be considered.
• Required experience:
  
  M.D. with a minimum of 3 years relevant drug development or clinical experience;
  Ph.D. with a minimum of 5 years; or M.S. with a minimum of 7 years, preference for regulatory experience.
• Excellent oral and written communication skills.
• Strong organizational abilities and proven capability to manage multiple projects simultaneously.
• Flexibility, strong scientific and analytical skills, attention to detail, and independent problem‑solving.

• Substantial experience in regulatory affairs.
• Therapeutic area experience in vaccines or infectious diseases, including antibacterial, antifungal, or antiviral agents.

• Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross‑Functional Collaboration, Detail‑Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing.

Salary range: $ – $.

The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.

We offer a comprehensive benefits package, including medical, dental, vision, insurance, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. Additional details can be found at

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

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