Global Regulatory Liaison & Strategy Lead (Hybrid)

Caraway Therapeutics, Inc.; Rahway (NJ); On-site; USD 173,000 - 273,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ seeks a Global Regulatory Liaison to develop and implement worldwide regulatory strategy for Oncology, Immunology and Devices programs, aiming to optimize labels and shorten approval timelines.

You will independently manage projects, serve as the global point of contact, interact with FDA/EMA/other authorities, coordinate submissions, and guide Product Development Teams on regulatory aspects across regions.

Qualifications

• BS degree in biological science, chemistry or related discipline, with minimum of 10 years drug development or clinical experience or regulatory affairs.
• MS with minimum of 10 years drug development or clinical experience or regulatory affairs.
• PhD with minimum of 7 years relevant experience.
• MD with minimum of 5 years relevant experience.

Responsibilities

• Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
• Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
• Provide direction to the staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
• Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
• Represents our Company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our Company’s teams for meetings with FDA at any phase of drug development.
• Lead cross-functional efforts to prepare for advisory committees.
• Coordinate interactions with foreign agencies through Regulatory Affairs Europe (RAE) and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.
• Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before release from our Company to external stakeholders.
• Represent GRA within our Company’s internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees (DRC), Product Development Team (PDT), Early Development Team (EDT), and labeling teams (LEAD)).
• Conducts initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.
• Participate in regulatory due diligence activities for licensing candidate review.

Skills

Clinical Research

Cross-Functional Teamwork

Drug Development

Global Regulatory

Oncology

Regulatory Affairs Management

Regulatory Communications

Regulatory Documents

Regulatory Filings

Regulatory Management

Regulatory Processes

Regulatory Strategies

Regulatory Submissions

Strategic Planning

Strategic Thinking

Education

B.S. Degree in biological science, chemistry or related discipline

M.S. with minimum of 10 years drug development or clinical experience or regulatory affairs

PhD with minimum of 7 years relevant experience

M.D. with minimum of 5 years relevant experience

Job description

Merck & Co., Inc. in Rahway, NJ seeks a Global Regulatory Liaison to develop and implement worldwide regulatory strategy for Oncology, Immunology and Devices programs, aiming to optimize labels and shorten approval timelines.

You will independently manage projects, serve as the global point of contact, interact with FDA/EMA/other authorities, coordinate submissions, and guide Product Development Teams on regulatory aspects across regions.