Paul Kowalczyk Email and Phone Number
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A detail-focused, results-oriented Regulatory and Quality professional with extensive and well rounded experience in both the medical device and pharmaceutical industries. Highly skilled and experienced in medical product advertising and promotion regulations, compliance and enforcement.I can be contacted at Paul.Kowalczyk1@verizon.net
Phathom Pharmaceuticals
View- Website:
- phathompharma.com
- Employees:
- 408
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Senior Director, Regulatory Advertising And PromotionPhathom PharmaceuticalsEast Hanover, Nj, Us
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Director Regulatory Advertising & PromotionPhathom Pharmaceuticals Apr 2022 - PresentFlorham Park, New Jersey, Us
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Associate Director Regulatory Affairs Advertising And PromotionLeo Pharma Inc. Us Nov 2018 - Apr 2022Ballerup, Dk, Dk -
Director Regulatory Affairs, Promotional ReviewNovo Nordisk Jan 2016 - Oct 2018Bagsværd, DkReview all promotional material within the hemophilia and rare blood disease product portfolio. -
Director Ra/QaNexcore Technology Inc. 2015 - 2016QA/RA member on the Executive Management Team.Primary contact and host for all FDA, Notified Body and customer audits.
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Corporate Staff Vp Regulatory Affairs Operations & PromotionC.R.Bard, Inc. 2010 - 2015Murray Hill, New Jersey, UsReviewed labeling and promotional material for all Bard Divisions as well as Bard Corporate.Company-wide subject matter expert on medical device advertising and promotion compliance.Established internal guidance and training programs related to promotional compliance. -
Corporate Staff Vp International Regulatory AffairsC.R.Bard Inc. 2005 - 2010Reviewed labeling and promotional material for all Bard Divisions as well as Bard Corporate.Led global regulatory initiatives focusing on Canada, Japan, China, South Korea and Mexico.Ensured transfer of all marketed products to the new Australian ARTG system by October 2007 deadline.Established joint SOPs in collaboration with Japanese Marketing Authorization Holder to govern RA and QA processes.Active member in several AdvaMed Working Groups.
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Director Corporate Regulatory AffairsC.R.Bard Inc. 1999 - 2005Reviewed labeling and promotional material for all Bard Divisions as well as Bard Corporate.Reviewed all US FDA premarket submissions.Conducted RA focused due diligence review of acquisition targets.Led CE labeling working group to address regulatory and customer requirements.
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Manager, Corporate Regulatory AffairsC.R.Bard, Inc. 1994 - 1999Created and maintained an internal CE Mark implementation guide.Assisted Divisions in achieving and maintaining EN46001 registration.Led team in selecting Notified Bodies and Translation Houses for multiple divisions.Tracked various 510k submission metrics to determine internal trends.
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Manager Regulatory ComplianceBecton Dickinson Vacutainer Systems 1992 - 1994Franklin Lakes, New Jersey, UsDeveloped and managed the divisional internal and vendor audit programs.Designed and created a Division Quality Manual.Conducted GMP, ISO and regulatory compliance training -
Compliance OfficerOsteonics 1988 - 1992Designed and implemented a comprehensive GMP audit compliance program.Conducted all internal and vendor GMP audits.Developed and conducted GMP training workshops.
Paul Kowalczyk Skills
Paul Kowalczyk Education Details
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Fairleigh Dickinson UniversityManagement -
Rutgers University - NewarkBotany
Frequently Asked Questions about Paul Kowalczyk
What company does Paul Kowalczyk work for?
Paul Kowalczyk works for Phathom Pharmaceuticals
What is Paul Kowalczyk's role at the current company?
Paul Kowalczyk's current role is Senior Director, Regulatory Advertising and Promotion.
What is Paul Kowalczyk's email address?
Paul Kowalczyk's email address is pa****@****ard.com
What is Paul Kowalczyk's direct phone number?
Paul Kowalczyk's direct phone number is +190827*****
What schools did Paul Kowalczyk attend?
Paul Kowalczyk attended Fairleigh Dickinson University, Rutgers University - Newark.
What skills is Paul Kowalczyk known for?
Paul Kowalczyk has skills like Advertising And Promotional Material, Fda, Medical Devices, Regulatory Affairs, Gmp, Quality Assurance, Validation, Iso 13485, Capa, Auditing, Pharmaceutical Industry, Iso.
Who are Paul Kowalczyk's colleagues?
Paul Kowalczyk's colleagues are Meghan Wilson, John Staton, Deeja Cole, Tony Migliazzo, Bill Pryor, Charlie Dolliole, Mba, Elizabeth Gonio.
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