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Robert J. Michalik, Esq., RAC
Principal Consultant
Professional Experience:
Bob has over 20 years experience working in the
biopharmaceutical and medical device industries.
Through his career, he has held a wide
variety of technical, quality and regulatory positions that
literally span the scope of new product development and
commercialization activities.
Education:
Suffolk University School of Law
Boston, MA
Doctor of Jurisprudence, May
1994
University of Massachusetts
Amherst, MA
B.S., Biochemistry, May
1981
Professional
experience includes:
Technical/Scientific experience
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Basic and applied research, product
development, technology transfer, manufacturing and
commercialization of biopharmaceuticals products using r-DNA
technology, cell therapy, small molecule synthesis (e.g.,
radiopharmaceuticals and peptides).
Regulatory Affairs experience
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Knowledge of legal and regulatory
requirements relating to investigational new drug
development, GxP compliance, FDA New Drug Applications, E.U.
Marketing Authorization Applications and post-marketing
regulatory compliance.
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Domestic and foreign regulatory experience
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Demonstrated achievements in drafting
submissions and successfully negotiating with drug, biologic
and medical device regulatory authorities.
Clinical Affairs experience
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Knowledge of legal and regulatory
requirements relating to clinical trial design, initiation,
GCP compliance and study report drafting and regulatory
submissions.
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Domestic and foreign regulatory experience
supporting INDs, IDEs and NDAs/BLAs, and European Union MAAs.
Quality Systems experience:
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Design Quality systems to ensure GxP
compliance
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Validation experience (equipment IQ, OQ & PQ,
analytical methods validation, process validation)
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Experience using various risk assessment
methods including
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Failure Modes & Effects Analysis (FMEA),
Fault Tree Analysis
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Compiled library of Policies, SOPs,
Protocols, Forms, Report templates suitable for tailoring
for specific purposes.
Click for
more detailed information on RJ Michalik's professional experience
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