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Onesmo Mpanju

Biopharmaceutical Regulatory Consultant, Biotechnology

Hi, I'm Onesmo Mpanju. Welcome to my profile!

Onesmo Mpanju's Bio:

I am an independent drug development consultant with over 23 years of experience in biopharmaceutical R&D, more than 13 years of those in regulatory affairs, including as a U.S. Food & Drug Administration (FDA) product reviewer and Regulatory Consulting Director with a global CRO. Currently based in Asia-Pacific, I have worked with biopharmaceutical companies, not-for-profit organizations, and government agencies from all corners of the globe. I have managed matrix regulatory project teams from diverse cultural and corporate or organizational backgrounds. My experience includes designing regulatory submission strategies for global development programs, CMC development planning for biologics (novel recombinant DNA products, vaccines, and complex/advanced biologics), biosimilars, and small molecules (including generic drugs), CMC due diligence auditing for asset acquisition, clinical trial compliance consulting for commercial and non-commercial sponsors, and management of clinical trial authorization (CTA/IND) or marketing (MAA/BLA) submission projects. I hold a Ph.D. in Experimental Medicine from the University of British Columbia, Canada. I am widely appreciated for public presentations at various scientific and industry events and publication in peer-reviewed scientific journals. I am acknowledged for being resourceful, adaptable, and self-directed with the ability to meet even the most challenging goals due to outstanding troubleshooting, analytical, and problem solving skills. I possess strong administrative skills combined with an extensive base of knowledge and experience to assist companies in meeting their corporate objectives I am focused and hardworking, self-motivated and result oriented with a mature approach and able to make an effective contribution to the performance of a team with good leadership and motivating capabilities. To know further about my experience and achievements, I can be reached via email ([email protected]).

Onesmo Mpanju's Experience:

  • Director, Regulatory Consulting at PPD

    June 2013 - May 2014

    - Responsible for supporting biopharmaceutical clients and leading regulatory and CMC business development growth in Asia-Pacific region - Providing consulting experties to Asia-Pacific based biopharmaceutical companies on regulatory strategy and clinical development and marketing registration requirements in global markets, including North America and European Union markets. - Global regulatory affairs lead on multiple regulatory projects, including as 1) lead regulatory strategist and CMC consultant on a novel whole inactivated HIV vaccine program; 2) novel long-acting anti-diabetic conjugated biologic; 3) novel synthetic peptide-based tolerizing vaccine for celiac disease; 4) Consulting on several biosimilar development programs; 5) CMC lead writer for autologous cellular therarpy products - Regulatory lead for biosimilar and complex and advanced therapeutic programs.

  • Director, Global Regulatory Affairs at PPD

    February 2006 - May 2013

  • Review Scientist at FDA

    2001 - 2006

  • CRTA Predoctoral Fellow at National Cancer Institute - Frederick

    1999 - 2001

  • Research Associate at Viridae Clinical Sciences

    1998 - 1999

  • Research Associate at British Columbia Centre for Excellence in HIV/AIDS

    1994 - 1998

  • Research Associate at UCB Pharma

    1991 - 1992

  • Principal Consultant at Independent Biopharmaceutical Product Development Consultant

    May 2014

Onesmo Mpanju's Education:

  • The University of British Columbia

    1995 – 2001
    Ph.D.

  • University of Ottawa / Universite d'Ottawa

    1993 – 1994
    Concentration: Microbiology & Immunology

  • Vrije Universiteit Brussel

    1990 – 1992
    Master of Medical & Pharmaceutical Research
    Concentration: Virology

  • University of Dar es Salaam

    1982 – 1985
    Bachelor of Pharmacy (BPharm)
    Concentration: Pharmacy



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