Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases

Job Description Global Regulatory Affairs Headquarters Principal Scientist responsible for development and implementation of global regulatory strategy for assigned projects in the Vaccines and Infectious Disease therapeutic area. Department Global Regulatory Affairs and Clinical Safety – Vaccine & Infectious Disease Primary Activities Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS. Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously. Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug. Provides leadership as head of the Global Regulatory Team, which coordinates cross‑functional regulatory support for development programs and marketed products. Represents the company with external organizations through direct communication with the FDA, including telephone calls and e‑mail; chairs meetings between the Company and FDA; prepares Company teams for meetings with FDA at all phases of drug development. Leads cross‑functional efforts to prepare for advisory committees and may speak at the advisory committee. Coordinates interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously. Reviews and provides final approval of Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigator Brochures before release from the company to external agencies and investigators. Represents Global Regulatory Affairs within internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees, Product Development Team, Early Development Team, and Label Evaluation and Development Team). Conducts initial Investigational New Drug application/Clinical Study Agreement content review and approval to facilitate initial approval by regulatory agencies for conduct of clinical trials. Participates in regulatory due diligence activities for licensing candidate review and works with business development partners in executing regulatory responsibilities to advance developmental compounds or support marketed products. Location USA – Pennsylvania – North Wales – Upper Gwynedd Additional Locations: USA – New Jersey – Rahway USA – Pennsylvania – Philadelphia – WeWork Extent of Travel 10% Qualifications, Skills & Experience Education Minimum Requirements M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline (or master’s with substantial experience in regulatory affairs to suggest equivalent ability). Required Experience And Skills M.D. with minimum of 3 years relevant drug development or clinical experience, or Ph.D. with minimum of 5 years relevant drug development experience, or M.S. with minimum of 7 years relevant drug development or clinical experience (preference if this experience is in regulatory affairs). Excellent communication skills (oral and written). Good organizational skills with proven ability to balance diverse activities or multiple projects simultaneously. Flexibility required. Strong scientific and analytical skills with attention to detail. Ability to achieve optimal results with limited day‑to‑day direction from the manager. Preferred Experience And Skills Substantial experience in regulatory affairs. Therapeutic area experience in vaccines or infectious diseases, including antibacterial, antifungal, or antiviral agents. Required Skills 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 Residency Requirement US and Puerto Rico residents only. Equal Employment Opportunity Statement 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. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights. EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Salary and Benefits Salary range: $210,400.00 – $331,100.00. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision health care and other insurance benefits for employee and family, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available. Employment Terms Employee Status: Regular Relocation: No relocation Visa Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Hybrid Shift: 1st – Day Job Posting End Date 07/25/2026 Requisition ID

R404836