Principal Scientist, Regulatory Liaison - Immunology

The Director (Principal Scientist), Global Regulatory Liaison reports to the Executive Director, General Medicine and is responsible for development and implementation of worldwide regulatory strategies for their assigned projects within the Immunology Therapeutic Area. The individual provides regulatory oversight for assigned products, to optimize product labeling and obtain shortest time to approval by global regulatory agencies. The Global Regulatory Liaison is expected to independently manage projects, functioning as the single, accountable, global point of contact on those project teams and interact with Worldwide Regulatory Agencies and/or subsidiaries regarding global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics.

This position requires a leader who is proactive, self motivated, and who can manage complex programs that may involve multiple indications, formulations, or external partners with direction from the Executive Director. Experience in immunology strongly preferred.

• Develops worldwide product regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies for assigned indications
• Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling
• Provides expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug
• Provides leadership to the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products
• Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and responsible for regulatory review and final approval for all submissions and associated documentation.
• Reviews and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets
• Interact independently with regulatory agencies (FDA, EMA, etc.), including leading meetings, teleconferences, and written communications
• Coordinate regional regulatory strategy and submissions through collaboration with Regulatory Affairs Europe (RAE) and local affiliate teams.
• Reviews Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures
• Prepares IND/CTAs for global studies related to investigational drugs/biologics
• Participates in regulatory due diligence activities for licensing candidate reviews

• B.S. or M.S with a minimum of 7 years of relevant drug development experience with majority in regulatory or
• M.D. or PhD/PharmD with a minimum of 5 years relevant drug development experience with three years in regulatory

• Strong strategic thinking, problem-solving, and continuous learning mindset.

• Effective communicator-both written and verbal-with 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 expertise in leading regulatory filings across global regions.

• Therapeutic area expertise in immunology

• Small and large molecule experience

• regulatory affairs experience in major markets (U.S., EU, Japan, China).

Immunology

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