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Ghulam Moinuddin

Regulatory Principal - Biologics at Freyr Solutions

Role
Regulatory Principal (Biologics Pharmaceuticals) at Freyr Solutions
Location
Mumbai, MH, IN
LinkedIn followers
500 followers
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About Ghulam Moinuddin

A Scientific Regulatory Professional with 17 years of extensive Regulatory Affairs and 5…

Experience

  1. Regulatory Principal (Biologics Pharmaceuticals)

    Freyr Solutions

    Jun 2019 — Present · Los Angeles, CA, US

    Regulatory Principal and Head - Project Delivery to develop Regulatory Strategy,Manage the overall functions of Global Regulatory Affairs Deliverables to EU; MEA cluster (KSA, UAE), APAC; African Countries, NAFDAC, French West African countries, India, and RoW countries.Regulatory Strategy: Develop Regulatory Strategy and lead Teams for deliverables for Teva, Sanofi Corporation, Glenwood, etc.Develop and lead the development and Regulatory Strategy for Biosimilarity of Low Molecular Weight Heparin (LMWH) for Abbott Healthcare Products B.V.(Netherlands).Post approval changes / Variations: Extension of Shelf life; Mfg. Process; Addition of Mfg. Site, etc.HA-Interactions: Presentations, Response to query, RTQs.NVX-CoV2373, its protein-based COVID-19 vaccine - SwissMedic; HSA; Saudi FDA, UAE.Labelling: Safety updates PI; Developing, review & approval of artworks (label, carton, PIL).DMFs: Compilation of the Drug Master File for Biologics and small molecules.Clients: Teva (Actavis, Ratiopharm, Pleva), Abbott B.V.(Netherlands), Sanofi, Roche, Bayer, Vifor,Ferring, Novavax Inc, Italfarmaco, Glenwood, Boehringer Ingelheim, Galderma.Laurels: Received Appreciation from Teva for quality and efficient deliverables and Approvals.Achievements: Orphan Drug Designation- The NDA for Givinostat (Duvyzat)- Italfor Duchene Muscular Dystrophy, a designated orphan drug with no known competitors within its mode of administration, is approved by US-FDA on 21st March 2024.Received Orphan Drug Designation and Recommendations for ENZ8422/GSK951 -Encube Ethicals for Netherton Syndrome (Rare and Orphan disease) Treatment Development Plan from Health Authority of India (DCGI/CDSCO).Obtained MA approvals and Mfg. Site registrations from MoHAP, SFDA, SwissMedic, NAFDAC, PPB, HSA, NPRA for Pharmaceuticals; biologics / Biosimilars (oxaliplatin, clopidogrel, carvidelol, filgrastim, liPeg-GCSF, copaxone, fremanezumab, mAbs and Novel COVID-19 vaccine).

Education

  • Drugs Control Department. Board of Examining Authority. Government of Karnataka, Karnataka State Pharmacy Council

    D.Pharm

    1992 — 1993

  • Bangalore University

    B.Pharm

    1993 — 1997

  • Rajiv Gandhi University of Health Sciences

    M.Pharm. (Pharmacology & Toxicology)

    1997 — 2000

  • Al-Ameen College of Pharmacy. Rajiv Gandhi University of Health Sciences, Karnataka. Bangalore.

    Doctor of Philosophy (Ph.D.)

    2001 — 2011

Skills

  • Pharmaceutics
  • Clinical Trials
  • Regulatory Submissions
  • Pharmaceutical Industry
  • Sop
  • Fda
  • Gmp
  • Biotechnology
  • Regulatory Affairs
  • Clinical Development
  • Anda
  • Glp
  • Annual Reports

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Ghulam Moinuddin — Regulatory Principal (Biologics Pharmaceuticals) at Freyr Solutions in Mumbai, MH, IN | Unifers