Senior Director Regulatory Affairs Liaison- General Medicine

Job Description Our Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs and maintain licensure for the General Medicine portfolio worldwide. We seek a leader with a growth mindset, demonstrated by intellectual curiosity and the ability to navigate complex regulatory challenges with rigor and professionalism. Position Overview The Senior Principal Scientist, Regulatory Affairs Liaison is responsible for the development and implementation of worldwide regulatory strategy for programs in the General Medicine therapeutic area with specific focus on cardiovascular/renal/respiratory development programs. The individual functions with a high degree of independence, providing strategic regulatory oversight to optimize labeling and achieve the shortest time to approval by regulatory agencies. The role requires adaptability to change and an entrepreneurial spirit. Key Responsibilities Report to the Executive Director or Associate Vice President, General Medicine Oversee the global regulatory strategy development and execution for assigned cardiovascular/renal/respiratory programs to optimize labeling and achieve the shortest approval timelines for multiple indications simultaneously Provide expert advice as the GRL to Early Development Teams (EDT) and Product Development Teams (PDT), serving as the regulatory single point‑of‑contact for products within and external to Global Regulatory Affairs and Clinical Safety on regulatory issues throughout the entire lifecycle of the drug Lead the Global Regulatory Team (GRT) for assigned programs, coordinating global, cross‑functional regulatory support for development and marketing programs Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets Represent the company with external organizations, including direct communication with the FDA via telephone, email, and meetings; chair FDA meetings and prepare internal teams for all FDA interactions Coordinate interactions with global regulatory agencies through Regulatory Affairs Europe, International, and subsidiary registration departments, providing strategic direction across multiple regions simultaneously Review and give final approval on Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before release to external agencies and investigators Represent Global Regulatory Affairs within internal company committees, providing regulatory advice and approval per committee charters (including therapeutic area Document Review Committees, PDT, EDT, and label development teams) Conduct initial IND/CSA content review and approval to facilitate agency approval for clinical trials Participate in regulatory due diligence activities for licensing candidate review Minimum Education & Experience Requirements Degree in biological science or related discipline B.S. with a minimum of 10 years relevant drug development experience, majority in regulatory affairs M.S. with a minimum of 10 years relevant drug development experience, majority in regulatory affairs M.D. with a minimum of 7 years relevant drug development experience, 5 years in regulatory affairs PhD/PharmD with a minimum of 7 years relevant drug development experience, 5 years in regulatory affairs Required Qualifications Ability to achieve optimal results with limited day‑to‑day direction from the Therapeutic Area Lead Outstanding interpersonal, verbal, and written communication, and negotiation skills Demonstrated leadership attributes, including experience building and leading high‑performing teams Preferred Experience Substantial experience with cardiovascular/renal/respiratory development programs, including pediatrics, orphan drug, and expedited development Substantial experience with both small and large molecule development programs Experience in regulatory affairs in global markets such as the EU, China, and Japan Prior GRL oversight of global regulatory submissions and approvals, including IND/CTAs and NDA/BLAs Knowledge and experience with medical devices (inhalers, auto‑injectors, pre‑filled syringes, etc.) Proficiency in AI applications (Co‑pilot, Chat GPT, etc.) Required Skills Corporate Commercial Cross‑Cultural Awareness Drug Development Exercises Judgment Global Health Global Market Healthcare Innovation Interpersonal Relationships In Vitro Diagnostics (IVD) Multiple Therapeutic Areas Oral Communications Orphan Drugs Pharmaceutical Regulatory Affairs Process Improvements Regulatory Affairs Compliance Regulatory Affairs Management Regulatory Communications Regulatory Compliance Regulatory Issues Regulatory Management Regulatory Strategy Development Written Communication Work Arrangement U.S. Hybrid Work Model: Effective September 5, 2023, employees in office‑based positions will follow a hybrid schedule of three on‑site days per week (Monday‑Thursday) with Friday remote, unless business critical tasks require on‑site presence. This model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions, or positions covered by a collective‑bargaining agreement (unless stated otherwise). Daily in‑person attendance is required for roles where remote work cannot reasonably satisfy job functions. Compensation and Benefits Salary range: $190,800.00 – $300,300.00. Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, and other insurance (for employee and family), retirement plan with 401(k), paid holidays, vacation, and compassionate and sick days. EEO Statement As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants 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 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 U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights and EEOC GINA Supplement. #J-18808-Ljbffr Merck & Co.