Senior Principal Scientist, Regulatory Liaison

Description:

The Senior Director (Sr. Principal Scientist), Regulatory Affairs Liaison reports to the Executive Director or Associate Vice President, General Medicine and is responsible for development and implementation of worldwide regulatory strategies for their assigned projects in the General Medicine Therapeutic Area, with a specific focus on Immunology development programs. The individual functions with a strategic focus, a high degree of independence and provides regulatory oversight for assigned products, to optimize product labeling and obtain shortest time to approval by global regulatory agencies.

You will independently manage projects, functioning as the single, accountable, global point of contact on those project teams and independently 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 with a strategic mindset, and is
-proactive, self-motivated, and who can independently manage complex programs that may involve multiple indications, formulations, or external partners. Prior experience in Immunology is strongly preferred.

• Works both independently and as a team member with integrity, precision, accomplishment, respect, inclusion and a strategic mindset.
• Develops worldwide regulatory strategies to optimize labeling and obtain shortest time to approval by regulatory agencies.
• Utilizes regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling.
• Provides expert regulatory advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for developmental compounds or marketed products throughout the entire product life cycle.
• 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 communications with regulatory agencies and is responsible for regulatory review of global applications and associated documentation.
• Reviews and provides final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
• Interacts independently with regulatory agencies (FDA, EMA, etc.), including leading of regulatory meetings, teleconferences, and written communications.
• Leads cross-functional efforts to prepare for FDA advisory committees, as applicable.
• 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 10 years of relevant drug development experience with majority in regulatory or
• M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five 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 strategies across global regions
• Global regulatory affairs experience in major markets (U.S., EU, Japan, China)
• Demonstrated leadership attributes; experienced at building and leading high performing teams or projects; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.

• Therapeutic area expertise in immunology
• Small and large molecule experience
• Prior people management experience.

Drug Development, Global Regulatory, Pharmaceutical Industry, Pharmaceutical Research, Product Registrations, Regulatory Affairs Management, Regulatory Communications, Regulatory Documents, Regulatory Processes, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Strategic Leadership

Immunology

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