[Hiring] Director, Global Regulatory Liaison @Merck

Role 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.

Qualifications

• 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

Requirements

• 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.

Benefits

• 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 https://jobs.merck.com/us/en/compensation-and-benefits .