Kevin Leiner

Chief Project Officer & VP Regulatory @Micropep Technologies

Durham, NC, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Feb 2023 — Present

Chief Project Officer & VP Regulatory @Micropep Technologies

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Accountable for R&D project portfolio management and global regulatory strategy, regulatory science, and regulatory compliance to deliver the company’s strategic objectives by advancing product candidates from research to commercialization.

EDUCATION

1990 — 1992

Long Island University, Southampton Campus

B.S., Marine Science

1994 — 2000

Texas A&M University

Ph.D., Zoology (Comparative Animal Physiology)

SKILLS

BiotechnologyGlpMolecular BiologyToxicologyProject ManagementRisk AssessmentRegulatory ScienceRegulatory AffairsRegulatory StrategyIssue ManagementTeam BuildingIn VivoAssay DevelopmentCellCell CultureProtein ChemistryValidationPharmacologyLife SciencesScienceProgram ManagementDrug DeliveryR&DEndocrinologyFunctional ManagementProject Risk Management

ABOUT KEVIN LEINER

An experienced leader of R&D programs, projects, and people across organizational and geographic boundaries • Successful track record of building and developing high performing teams, leading people through change, creating sustainable organizations, and developing people for greater organizational impact and career satisfaction• Proven ability to quickly become expert in new areas, to identify critical concepts and information, and to solve problems, exercise sound judgment, and make timely decisions• An articulate and credible advocate for scientific positions and risk-based decision making with leading regulatory agencies in Europe, Asia, and North and South America to address regulatory and safety concerns Specialties: Strategic direction and change leadership; portfolio, program, and project management; functional planning and resource management; product safety; regulatory affairs; crop protection development; agricultural biotechnology / GM trait development / plant-incorporated protectants; RNA-based plant protection, biological plant protection and biostimulants, microbial pest control agents; risk assessment; laboratory start up and operations; sourcing strategy; pharmacology; toxicology.

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