Global Regulatory Lead, Immunology — Remote

Merck; Phoenix (AZ); Presencial; USD 173 000 - 273 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Medical benefits

Retirement benefits (401(k))

Remote work options

Resumo da oferta

Merck in Rahway, NJ, seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects, optimize labeling, and shorten time to approval by global agencies. You will act as the single accountable global contact on project teams and interact with FDA, EMA, and subsidiaries throughout the product life cycle.

This role demands proactive leadership, strong regulatory submissions experience, and proven experience in global submissions.

Qualificações

• Extensive experience in drug development regulatory strategy.
• Proven ability to lead global regulatory filings.
• Experience with FDA/EMA interactions.
• Strong communication and negotiation skills.

Responsabilidades

• Develops worldwide regulatory strategies to optimize labeling and time to approval.
• Assesses regulatory landscape to enable speed-to-market and targeted labeling.
• Provides leadership as Global Regulatory Lead to cross-functional teams.
• Coordinates submissions and interactions with regulatory agencies globally.
• Reviews study protocols for regulatory approvals in key markets.
• Interacts with FDA/EMA and regional affiliates as needed.
• Leads regulatory due diligence for licensing and alliances.

Conhecimentos

Strategic leadership

Regulatory affairs

Regulatory submissions

Interfacing with Health Authorities

Cross-functional leadership

Formação académica

Bachelor or higher in life sciences

MD/PhD/PharmD with regulatory experience

Descrição da oferta de emprego

Merck in Rahway, NJ, seeks a Director (Principal Scientist), Global Regulatory Liaison to lead worldwide regulatory strategies for Immunology projects, optimize labeling, and shorten time to approval by global agencies. You will act as the single accountable global contact on project teams and interact with FDA, EMA, and subsidiaries throughout the product life cycle.

This role demands proactive leadership, strong regulatory submissions experience, and proven experience in global submissions.