[Remote] Senior Principal Scientist, Regulatory Liaison

Note: The job is a remote job and is open to candidates in USA. Merck is a pharmaceutical company seeking a Senior Principal Scientist, Regulatory Liaison to lead worldwide regulatory strategies for assigned General Medicine projects, with a focus on immunology development programs. The role provides global regulatory oversight, le cross-functional regulatory teams, manages agency interactions and submissions, and supports products throughout their life cycle.

Responsibilities

• Works both independently and as a team member with integrity, precision, accomplishment, respect, inclusion and a strategic mindset
• Develops worldwide regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies
• Utilizes regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling
• Provides expert regulatory advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for developmental compounds or marketed products throughout the entire product life cycle
• 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 communications with regulatory agencies and is responsible for regulatory review of global applications and associated documentation
• Reviews and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets
• Interacts independently with regulatory agencies (FDA, EMA, etc.), including leading of regulatory meetings, teleconferences, and written communications
• Le cross-functional efforts to prepare for FDA advisory committees, as applicable
• 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

Skills

• B.S. or M.S with a minimum of 10 years of relevant drug development experience with majority in regulatory or
• M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory
• 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 strategies across global regions
• Global regulatory affairs experience in major markets (U.S., EU, Japan, China)
• Demonstrated leadership attributes; experienced at building and leading high performing teams or projects; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities
• Drug Development
• Global Regulatory
• Pharmaceutical Industry
• Pharmaceutical Research
• Product Registrations
• Regulatory Affairs Management
• Regulatory Communications
• Regulatory Documents
• Regulatory Processes
• Regulatory Strategies
• Regulatory Strategy Development
• Regulatory Submissions
• Strategic Leadership
• Prior experience in Immunology is strongly preferred
• Therapeutic area expertise in immunology
• Small and large molecule experience
• Prior people management experience
• Immunology

Benefits

• Annual bonus and long-term incentive, if applicable
• 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
• Remote work

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