Expertise in US, European, and international regulatory affairs

GABRIEL LEBOVIC

DIRECTOR OF REGULATORY AFFAIRS-REMOTE

E-MAIL: ***********@*******.***

PHONE: 215-***-****

PROFESSIONAL SKILLS:

• Extensive hands on experience in pharmaceutical regulatory affairs and interactions with US FDA, SFDA, HPB, EMEA, MHRA, BfArM, AFSAP, PMDA, TGA and 30 European Heath Authorities

• Proven leadership and program management experience with multi therapeutics drugs and biologics

• Focused to think and work strategically, while critically evaluating risks to regulatory activities

• Trained to work strategically within a complex development program for IR, MR, Sterile Injectable, Lyophilized, CV, CNS, GI, Oncology, Pulmonary, Dermatological Drugs, Biologics, Combination Products

• Successful contribution to regulatory approvals of drugs and biologics at a global and regional level

• A scientific, CMC, preclinical and clinical understanding of the regulatory sciences and labeling

• Demonstrated strategic thinking, influencing, innovative leadership, excellent oral and written communication skills, Target Profiles, Core Labeling Information and e-CTD Regulatory Dossiers

SUMMARY OF ACCOMPLISHMENTS:

• Developed regulatory strategies for CV, CNS, GI, Oncology, Pulmonary Drugs and Biologics

• Led corporate teams in scientific, regulatory, advisory meetings with FDA, EMEA, HPB, PMDA

• Directed preparation of 20-IND, 10-NDA, 6-505(b)(2)-NDA, 4-MAA, 2-BLA, 2-JNDA dossiers

• Obtained approvals for CV, CNS, GI, Oncology, Pulmonary, Ophthalmic Drugs and Biologics

• Saved $ 500,000,000 in preclinical, clinical, CMC product development and technology transfer

• Utilized CMC expertise in fast track preclinical and clinical development of drugs and biologics

• Interfaced with business partners, R&D, patent, clinical, medical, statistical, CRO, CMO, S&M

PROFESSIONAL EXPERIENCE:

GLOBAL REGULATORY CONSULTANTS, LTD., Philadelphia, PA 2007-Present

Director of Regulatory Affairs

• Developed regulatory strategies for CV, CNS, GI, Oncology, Pulmonary Drugs and Biologic s

• Led corporate teams in scientific, regulatory, advisory meetings with FDA, EMEA, HPB, PMDA

• Prepared briefing packages for scientific, regulatory, advisory meetings with FDA, EMEA, PMDA

• Authored pre-IND, EOP-2, pre-NDA, pre-BLA, pre-MAA and pre-JNDA briefing documents

• Directed preparation of 6-IND, 2-NDA, 4-505(b)(2)-NDA, 2-BLA, 2-MAA, 1-JNDA dossier

• Saved $ 300,000,000 in preclinical clinical, CMC development costs of drugs, biologics, vaccines

• Utilized CMC expertise in fast track preclinical and clinical development of combination products

• Interfaced with PD, R&D, ADR, preclinical, clinical, CMC, medical, CRO, CMO, manufacturing

• Interfaced with business partners, R&D, patent, clinical, medical, statistical, CRO, CMO, S&M

TEVA PHARMACEUTICALS, Bala-Cynwyd, PA 2004-2006

Director of Regulatory Affairs

• Originated regulatory strategy for CV, CNS, GI, Oncology, Pulmonary, Drugs and Biologics

• Led corporate teams in scientific-regulatory-advisory meetings with FDA, EMEA, HPB, PDMA

• Generated briefing packages for regulatory meetings with FDA, MHRA, EMEA, AFSAP, BfArM

• Utilized CMC expertise in accelerated preclinical, clinical development of drugs and biologics

• Prepared 4-IND, 1-NDA, 2-505(b) (2)-NDA, 1-BLA, 20-CTA, 1-MAA and 1-JNDA dossiers

• Saved $ 100,000,000 in preclinical clinical, CMC development costs of drugs, biologics, vaccines

• Interfaced with R&D, PD, ARD, patent, clinical, medical, statistical, CMC, CRO, CMO, CDMO

DEY-MERCK, KGAA, Napa, CA 2002-2004

Director of Regulatory Affairs

• Designed regulatory strategies for CV, CNS, GI, Oncology, Pulmonary Drugs and Biologics

• Led scientific-regulatory, advisory meetings with FDA, HPB, MHRA, AFSAP, BfArM, EMEA

• Directed preparation of 4-IND, 2-NDA, 2-505-(b) (2)-NDA, 20-CTA, 1-MAA, 1-BLA, 1-JNDA

• Saved $ 100,000,000 in preclinical clinical, CMC development costs of drugs, biologics, vaccines

• Utilized CMC expertise in accelerated preclinical, clinical development of drugs and biologics

• Interfaced with R&D, PD, ARD, patent, clinical, medical, statistical, CMC, CRO, CMO, CDMO

• Hired, trained and mentored a team of regulatory professionals in preparation of e-CTD dossiers

ViroPharma-Sanofi-Aventis-Wyeth-Joint Venture, Exton, PA 2000-2002

Managing Director of Regulatory Affairs

• Designed regulatory strategies for CV, CNS, GI, Oncology, Pulmonary Drugs and Biologics

• Led scientific-regulatory, advisory meeting with FDA, HPB, MHRA, AFSAP, BfArM, EMEA

• Prepared pre-IND, EOP-2, pre-NDA, pre-BLA, pre-MAA and pre-JNDA briefing documents

• Utilized CMC expertise in accelerated preclinical, clinical development of drugs and biologics

• Directed preparation of 4-IND, 1-NDA, 1-505-(b) (2)-NDA, 20-CTA, 1-MAA, 1-BLA, 1-JNDA

• Interfaced with R&D, PD, ARD, patent, clinical, medical, statistical, CMC, CRO, CMO, CDMO

• Hired, trained and mentored a team of regulatory professionals in preparation of e-CTD dossiers

PERRIGO, INC., New York City, NY 1996-2000

Director of Regulatory Affairs

• Developed regulatory strategies for CV, CNS, GI, Oncology, Pulmonary, Drugs and Biologics

• Led corporate team in scientific, regulatory, advisory meetings with FDA, HPB, MHRA, AFSAP

• Utilized CMC expertise in accelerated preclinical, clinical development of drugs and biologics

• Prepared 6-IND, 2-NDA, 4-505(b) (2)-NDA, 30-CTA, 10-IMPD, 2-MAA, 1-JNDA dossiers

• Interfaced with R&D, PD, ARD, patent, clinical, medical, statistical, CMC, CRO, CMO, CDMO

• Hired, trained and mentored a team of regulatory professionals in preparation of e-CTD dossiers

IMPAX PHARMA, Inc., Philadelphia, PA 1994-1996

Director of Regulatory Affairs

• Developed regulatory strategies for CV, CNS, GI, Oncology, Pulmonary, Drugs and Biologics

• Led corporate team in scientific, regulatory, advisory meetings with FDA, HPB, MHRA, AFSAP

• Utilized CMC expertise in accelerated preclinical, clinical development of drugs and biologics

• Directed preparation of 6-IND, 2-NDA, 2-505(b) (2)-NDA, 1-MAA, 1-BLA, 1-JNDA dossiers

• Interfaced with R&D, PD, ARD, patent, clinical, medical, statistical, CMC, CRO, CMO, CDMO

• Hired, trained and mentored a team of regulatory professionals in preparation of e-CTD dossiers

TELEDYNE PHARMA, Chicago, IL 1988-1994

Director of Regulatory Affairs

• Developed sound regulatory strategies for CV, GI, CNS, cancer, pulmonary, drugs and biologics

• Led corporate team in scientific, regulatory, advisory meetings with FDA, HPB, MHRA, AFSAP

• Utilized CMC expertise in accelerated preclinical, clinical development of drugs and biologics

• Prepared 6-IND, 2-NDA, 4-505(b) (2)-NDA, 1-MAA, 1-BLA and 2 -JNDA marketing dossiers

• Interfaced with R&D, PD, ARD, patent, clinical, medical, statistical, CMC, CRO, CMO, CDMO

• Hired, trained and mentored a team of regulatory professionals in preparation of e-CTD dossiers

EDUCATION:

Bachelor of Science, Chemistry

BROOKLYN COLLEGE; Brooklyn, NYC

Master of Arts, Chemistry

BROOKLYN COLLEGE; Brooklyn, NYC

PhD Chemistry Course Work

CITY COLLEGE OF NEW YORK; NYC

PROFESSIONAL MEMBERSHIP:

RAPS, DIA, PDA, AAPS, ISPE, ACRP

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