Global Regulatory Lead – Immunology (Remote)

Merck; Honolulu (HI); Remoto; USD 191.000 - 300.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Long-term incentive

Comprehensive benefits

Descrizione del lavoro

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

You will be the global point of contact with regulatory agencies, shaping labeling and approvals across multiple indications and with external partners. This strategic leadership role requires independent program management, strong communication with Health Authorities (FDA/EMA), and a track record of

Competenze

• BS or MS with a minimum of 10 years of drug development experience with majority in regulatory
• MD or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory

Mansioni

• Develops worldwide regulatory strategies to optimize labeling and shorten time to approval by global agencies.
• Provides expert regulatory advice as the Global Regulatory Lead to Product Development Teams.
• Leads cross-functional regulatory support for development programs and marketed products.
• Coordinates regulatory submissions and communications with agencies (FDA, EMA, etc.).
• Prepares IND/CTAs and participates in regulatory due diligence for licensing candidates.

Conoscenze

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

Formazione

BS/MS in a relevant field

MD/PhD/PharmD with regulatory experience

Descrizione del lavoro

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

You will be the global point of contact with regulatory agencies, shaping labeling and approvals across multiple indications and with external partners. This strategic leadership role requires independent program management, strong communication with Health Authorities (FDA/EMA), and a track record of