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Click here or scroll down to respond to this candidateCandidate's Name
DIRECTOR OF REGULATORY AFFAIRS-REMOTE
E-MAIL: EMAIL AVAILABLE
PHONE: PHONE NUMBER AVAILABLE
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 |
