Senior Principle Scientist, Regulatory Liaison (Remote)

at Merck in Augusta, Maine, United States

Job Description

The Global Regulatory Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the Immunology therapeutic area. Acting as the single, accountable global point of contact, with significant experience, the Liaison provides strategic regulatory oversight to accelerate approvals and optimize product labeling.

This position requires an experienced leader who is proactive, self-motivated and who can independently manage 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. Global Immunology submission experience in IBD strongly preferred.

Primary Responsibilities

+ Develop and lead global regulatory strategies to support multiple indications, optimizing labels and achieving timely regulatory approvals.

+ Serve as an experienced 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 and independently lead 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 and may include a speaking role.

+ 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. or M.S. in biological sciences, chemistry, or