Remote Regulatory Strategy Lead, Immunology

Merck; Boston (MA); À distance; USD 191 000 - 300 000; Plein temps

Avantages offerts par ce poste

Medical benefits

Dental benefits

Vision benefits

Retirement benefits

401(k)

Résumé du poste

Merck in Boston, MA seeks a Senior Director (Sr. Principal Scientist, Regulatory Affairs Liaison) to lead worldwide regulatory strategies for General Medicine immunology programs.

You will guide regulatory oversight across product life cycles, interact with FDA/EMA, prepare filings, and lead teams to achieve faster approvals. Applicants should have 10+ years in regulatory or 7+ with MD/PhD, strong strategic leadership, and experience with major Health Authorities.

Qualifications

• Strong strategic thinking and leadership capabilities.
• Experience with major Health Authorities (FDA/EMA).
• Global regulatory experience across major markets.

Responsabilités

• Develop worldwide regulatory strategies to optimize labeling and speed approvals.
• Provide expert regulatory advice as Global Regulatory Lead to Product Development Teams.
• Lead cross-functional regulatory support for development programs and marketed products.
• Coordinate submissions, communications, and regulatory reviews globally.
• Interact with regulatory agencies and lead regulatory meetings.
• Prepare for FDA advisory committees and review study protocols when needed.
• Oversee regulatory due diligence for licensing reviews.

Connaissances

Global Regulatory

Regulatory Strategy

Regulatory Submissions

Regulatory Leadership

Regulatory Communications

Drug Development

Project Leadership

Formation

B.S./M.S in science

M.D./PhD/PharmD

Description du poste

Merck in Boston, MA seeks a Senior Director (Sr. Principal Scientist, Regulatory Affairs Liaison) to lead worldwide regulatory strategies for General Medicine immunology programs.

You will guide regulatory oversight across product life cycles, interact with FDA/EMA, prepare filings, and lead teams to achieve faster approvals. Applicants should have 10+ years in regulatory or 7+ with MD/PhD, strong strategic leadership, and experience with major Health Authorities.