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Merck

Sr. Principal Scientist (Sr. Director) - Regulatory Liaison

Merck

full time · Senior

$190,800 – $300,300

Listed on Merck’s own careers site. You apply with them directly — we never stand between you and the employer.

What this role is

A senior regulatory leadership role managing global approval strategies for cardiovascular and metabolic drugs from development through market launch. This suits experienced regulatory scientists who have led complex submissions with multiple indications and want to shape product strategy while working directly with FDA and international health authorities.

Our summary, not Merck’s wording. The full posting is on their site.

Skills this role names

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What they ask for

Required

  • Bachelor's degree in biological science or related field with 10+ years drug development experience (majority in regulatory affairs), or Master's with 10+ years drug development (majority regulatory affairs), or MD with 7+ years drug development (5+ in regulatory affairs), or PhD/PharmD with 7+ years drug development (5+ in regulatory affairs)
  • Ability to work independently with limited oversight
  • Outstanding interpersonal and written communication skills
  • Demonstrated leadership and team-building experience

Nice to have

  • Substantial cardiovascular, renal, or respiratory program experience including pediatric and orphan drugs
  • Experience with both small and large molecule programs
  • Regulatory affairs experience in EU, China, or Japan
  • Prior Global Regulatory Lead oversight of IND/CTA and NDA/BLA submissions
  • Knowledge of device platforms (inhalers, auto-injectors, pre-filled syringes)
  • Proficiency with AI tools (Copilot, ChatGPT)

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