Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases

Overview The Regulatory Affairs Headquarters Principal Scientist is responsible for development and implementation of global regulatory strategy for their 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 our company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chairs meetings between our Company and FDA; prepares our 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, Investigators Brochures before release from our company to external agencies and investigators. Represents Global Regulatory Affairs (GR) 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. Other degrees such as master's with substantial experience in regulatory affairs to suggest equivalent ability to function in this position. Required Experience And Skills M.D. with minimum of 3 years relevant drug development or clinical experience required, or Ph.D. with minimum of 5 years relevant drug development experience required, 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 (both oral and written). Good organizational skills with a proven ability to simultaneously balance diverse activities or multiple projects. 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. Experience with 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 Preferred Skills Current Employees apply HERE Current Contingent Workers apply HERE Location and Policy US And Puerto Rico Residents Only. Our company is committed to inclusion, providing equal opportunities to all employees and applicants. For accommodation during the application or hiring process, please click here. Requirements 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 diverse experiences and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas come together in an inclusive environment. Learn more about your rights, including under California, Colorado and other US State Acts. The salary range for this role is $210,400.00 - $331,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. 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 and other insurance benefits (for employee and family), retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at You can apply for this role through The application deadline is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance. Los Angeles Residents Only: We will consider all qualified applicants, including those with criminal histories, in a manner consistent with applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Search Firm Representatives Please Read Carefully: Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms without a valid written search agreement will be the property of the company. No fee will be paid where no pre-existing agreement is in place. Employee Status: Regular. Relocation: No relocation. VISA Sponsorship: No. Travel Requirements: 10%. Flexible Work Arrangements: Hybrid. Shift: 1st - Day. Valid Driving License: No. Hazardous Materials: N/A. Job Posting End Date: 07/25/2026. Requisition ID: R404836 #J-18808-Ljbffr Merck