Merck
Director/Principal Scientist, Regulatory Affairs Liaison
Merck, Rahway, New Jersey, United States, 07065
Global Regulatory Liaison
At the heart of innovation, our Regulatory Affairs team plays a vital role in delivering new medical advancements to patients around the world. By facilitating seamless communication and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the leading edge of healthcare, we bring safe, reliable, and compliant medical products, practices, and solutions to the global market. The Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the Oncology, Immunology, and Devices therapeutic areas. Acting as the single, accountable global point of contact, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling. This position requires a proactive, self-motivated individual who can operate independently while managing complex programs that may involve multiple indications, formulations, or external partners. The Liaison engages directly with global regulatory authorities to ensure successful registration and compliance. Primary Responsibilities Develop and lead global regulatory strategies to support multiple indications, optimizing labels and achieving timely regulatory approvals. Serve as the worldwide regulatory representative on Asset or Product Development Teams and act as the regulatory single point-of-contact for assigned products across GRACS and external partners. Provide expert regulatory guidance to cross-functional development teams and regional subsidiaries throughout the product life cycle. Oversee the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. Interact independently with regulatory agencies (FDA, EMA, etc.), including leading meetings, teleconferences, and written communications. Lead cross-functional teams in preparation for regulatory advisory committee meetings. Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. Provide final regulatory review and approval of: Worldwide marketing applications Clinical study protocols and reports Investigator brochures Local registration study protocols for secondary markets Represent Global Regulatory Affairs on internal committees (e.g., DRC, ADT/PDT, EDT, LEAD) to provide strategic regulatory input and approvals. Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. Participate in regulatory due diligence activities for in-licensing opportunities. Education Requirements B.S. in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. M.S. with 10+ years of experience. Ph.D. with 7+ years of experience. M.D. with 5+ years of experience. Required Experience and Skills Proven ability to operate independently with minimal direction and deliver results. Strong strategic thinking, problem-solving, and continuous learning mindset. Effective communicatorboth written and verbalwith the ability to influence, lead, and negotiate across levels and functions. Experience leading or supporting direct interactions with major Health Authorities (e.g., FDA, EMA). Demonstrated success in managing regulatory filings across global regions. Preferred Experience and Skills Therapeutic area expertise in Oncology or Immunology. Experience with biologics, vaccines, or mRNA therapeutics. Significant regulatory affairs experience in major markets (U.S., EU, Japan, China).
At the heart of innovation, our Regulatory Affairs team plays a vital role in delivering new medical advancements to patients around the world. By facilitating seamless communication and establishing robust procedures, we ensure swift, organized compliance with global regulatory agencies. As an international network on the leading edge of healthcare, we bring safe, reliable, and compliant medical products, practices, and solutions to the global market. The Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the Oncology, Immunology, and Devices therapeutic areas. Acting as the single, accountable global point of contact, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling. This position requires a proactive, self-motivated individual who can operate independently while managing complex programs that may involve multiple indications, formulations, or external partners. The Liaison engages directly with global regulatory authorities to ensure successful registration and compliance. Primary Responsibilities Develop and lead global regulatory strategies to support multiple indications, optimizing labels and achieving timely regulatory approvals. Serve as the worldwide regulatory representative on Asset or Product Development Teams and act as the regulatory single point-of-contact for assigned products across GRACS and external partners. Provide expert regulatory guidance to cross-functional development teams and regional subsidiaries throughout the product life cycle. Oversee the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. Interact independently with regulatory agencies (FDA, EMA, etc.), including leading meetings, teleconferences, and written communications. Lead cross-functional teams in preparation for regulatory advisory committee meetings. Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams. Provide final regulatory review and approval of: Worldwide marketing applications Clinical study protocols and reports Investigator brochures Local registration study protocols for secondary markets Represent Global Regulatory Affairs on internal committees (e.g., DRC, ADT/PDT, EDT, LEAD) to provide strategic regulatory input and approvals. Conduct initial content review and approval for IND/CSA submissions to enable clinical trial initiation. Participate in regulatory due diligence activities for in-licensing opportunities. Education Requirements B.S. in biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience. M.S. with 10+ years of experience. Ph.D. with 7+ years of experience. M.D. with 5+ years of experience. Required Experience and Skills Proven ability to operate independently with minimal direction and deliver results. Strong strategic thinking, problem-solving, and continuous learning mindset. Effective communicatorboth written and verbalwith the ability to influence, lead, and negotiate across levels and functions. Experience leading or supporting direct interactions with major Health Authorities (e.g., FDA, EMA). Demonstrated success in managing regulatory filings across global regions. Preferred Experience and Skills Therapeutic area expertise in Oncology or Immunology. Experience with biologics, vaccines, or mRNA therapeutics. Significant regulatory affairs experience in major markets (U.S., EU, Japan, China).