John Pakulski
Biotech Executive and Advisor
- Role
- SVP Global Regulatory Affairs at Prolong Pharmaceuticals
- Location
- Charleston, SC, US
- LinkedIn followers
- 500 followers
About John Pakulski
John Pakulski has 40 years of experience in global regulatory affairs and drug, biologics and biosimilar development leading to approvals across multiple therapeutic areas while working for Pfizer, Aventis, Sanofi, Novartis, Kashiv Biosciences and Prolong Therapeutics. John specializes in innovative regulatory strategies and leveraging regulatory pathways, regulations and guidances along with scientific evidence to streamline and expedite the development process. For over 20 years he has built and led regulatory teams. He has broad expertise on the regulatory aspects of the technical, preclinical and clinical development of biologics and drugs. John is a pharmacist and graduate of Rutgers College of Pharmacy. John helped pioneer the biosimilar pathway in the US. As Head of Biopharmaceuticals at the Sandoz division at Novartis, he was involved with the approval of the first biosimilar in the US. He served as Vice Chairman of the Biosimilar Council, chair of the AAM Biosimilars Working Group, chair of Biosimilar Forum Regulatory Committee and represented industry during the first two Biosimilar User Fee Negotiations with FDA. His efforts in shaping US policy and the biosimilar regulatory environment resulted in John receiving 2 President’s awards at Novartis.
Experience
SVP Global Regulatory Affairs
Mar 2021 — Present · South Plainfield, NJ, US
Skills
- Pharmaceuticals
- Regulatory Requirements
- Ind
- Medical Devices
- Regulations
- Regulatory Strategy
- Anda
- Biosimilars
- Therapeutic Areas
- Drug Development
- Biopharmaceuticals
- Pharmacokinetics
- Ectd
- Gmp
- Biologics
- Pharmaceutical Industry
- Fda
- Regulatory Affairs
- Clinical Trials
- Clinical Development
- Strategy
- Regulatory Submissions
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