Principal Scientist, Regulatory Liaison - Immunology

Job Description The Director (Principal Scientist), Global Regulatory Liaison reports to the Executive Director, General Medicine and is responsible for development and implementation of worldwide regulatory strategies for their assigned projects within the Immunology Therapeutic Area. The individual provides regulatory oversight for assigned products, to optimize product labeling and obtain shortest time to approval by global regulatory agencies. The Global Regulatory Liaison is expected to independently manage projects, functioning as the single, accountable, global point of contact on those project teams and interact with Worldwide Regulatory Agencies and/or subsidiaries regarding global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics. This position requires a leader who is proactive, self motivated, and who can manage complex programs that may involve multiple indications, formulations, or external partners with direction from the Executive Director. Experience in immunology strongly preferred. Key Functions Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies for assigned indications Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling Provides expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug Provides leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation. Reviews and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets Interact independently with regulatory agencies (FDA, EMA, etc.), including leading meetings, teleconferences, and written communications Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures Prepares IND/CTAs for global studies related to investigational drugs/biologics Participates in regulatory due diligence activities for licensing candidate reviews Minimum Education & Experience Requirements B.S. or M.S with a minimum of 7 years of relevant drug development experience with majority in regulatory or M.D. or PhD/PharmD with a minimum of 5 years relevant drug development experience with three years in regulatory Required Experience Strong strategic thinking, problem-solving, and continuous learning mindset. Effective communicator—both written and verbal—with the ability to influence, lead, and negotiate across levels and functions. Experience leading or supporting direct interactions with major Health Authorities (e.g., FDA, EMA). Demonstrated expertise in leading regulatory filings across global regions. Preferred Experience Therapeutic area expertise in immunology Small and large molecule experience regulatory affairs experience in major markets (U.S., EU, Japan, China). Required Skills Drug Development, Global Regulatory, Pharmaceutical Industry, Pharmaceutical Research, Product Registrations, Regulatory Affairs Management, Regulatory Communications, Regulatory Processes, Regulatory Strategies, Regulatory Submissions, Strategic Leadership Preferred Skills Immunology Eligibility and Working Conditions Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Remote Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Equal Opportunity and Inclusion Statements 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. Learn more about your rights, including under California, Colorado and other US State Acts Salary and Benefits The salary range for this role is $173,200.00 - $272,600.00 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, but not limited to relevant 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. Available benefits include medical, dental, vision healthcare 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 at Legal and Background Disclosures 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 for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance Company Overview Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. #J-18808-Ljbffr MSD Malaysia