David Plant Email and Phone Number
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David Plant is a Senior Global Regulatory Lead at CSL at CSL. He possess expertise in regulatory affairs, fda, clinical development, pharmaceuticals, vaccines and 11 more skills. Colleagues describe him as "David is a talented, thoughtful professional. He has a proven track record of many successes across different therapeutic areas and with several Regulatory agencies across the globe. I have worked with David on several projects and witnessed his strategic thinking, ability to resolve complex issues and work under pressure to deliver projects on time. David also has a keen commercial awareness and excellent people management skills which, combined with his proven track record will be invaluable to any organisation at a senior level."
Csl
View- Website:
- csl.com.au
- Employees:
- 14897
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DirectorCsl Sep 2022 - PresentMelbourne, Victoria, AustraliaGlobal regulatory R&D lead for gene therapies
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Associate DirectorCsl Seqirus Jan 2020 - Sep 2022Parkville, Victoria, AustraliaDefine and implement global regulatory strategyData analysis and interpretation from multiple studies for preparation of clinical dossier Manage submissions for EMA, FDA, TGA, Swiss Medic, Health Canada, TFDA, ANMATManagement of regulatory affairs team
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Senior ManagerSeqirus Aug 2017 - Dec 2019Parkville, AustraliaDefine and implement regulatory strategy for vaccines and antiviral productsPreparation of marketing authorization in NZ, Canada, WHO, Argentina, Korea, MexicoCompany representative for TGA negotiationsManagement of regulatory affairs team
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Senior Regulatory Advisor/Principal AssociateBiocsl Apr 2011 - Aug 2017Melbourne, AustraliaManaged partner company, clinical data analysis and CSR preparation for clinical supplement. Achieved FDA approval within statutory timeframeAppointed FDA company representative and established positive relationship with evaluators Revised several regulatory processes which saved 0.2 FTE and enabled early FDA approval and market supply Supported Quality Assurance during FDA site audits and contributed to closure of FDA warning letter within 12 months of issueManaged 2 regulatory affairs staff, provided guidance, mentored, conducted performance reviews, interviewed and recruited a new team member
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Senior Regualtory Affairs AssociateCsl Jan 2008 - Mar 2011Melbourne, AustraliaSuccessfully managed 2 clinical development projects (multiple clinical trials (20 to 40 participants in each, for separate indications and literature based extension of indications)Compiled and submitted two Category 1 and two New Medicine Applications which included writing all non-clinical, clinical and CMC sectionsNegotiated requirements for submission with TGA evaluators Analysed clinical data and reviewed 2 clinical study reports Prepared clinical summaries and clinical overviews in liaison with 3 external key opinion leaders Prepared applications and maintained registration for clinical trials conducted in Australia (CTX/CTN) and New Zealand (SCOTT) Prepared pre-ACPM response and led post-ACPM negotiations with TGAEnsured successful registration and market supply in Australia and New Zealand
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Regulatory Affairs AssociateCsl Nov 2005 - Dec 2007Melbourne, AustraliaMaintained product portfolio 6 products in in Australia, New Zealand and South East AsiaPrepare regulatory dossiers for manufacturing and labeling changesCompleted the preparation of an ASEAN electronic registration dossier
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Senior Research FellowUniversity Of Melbourne May 2000 - Oct 2005Melbourne, AustraliaSuccessfully sourced funding (~$500,000) to support multiple original research projects Completed multiple research projects which resulted in publications of 29 papers in peer-reviewed journals which include 10 first authored papersInvited peer reviewer of 2 scientific journals Presented research findings at 12 national and 3 international scientific conferences
David Plant Skills
David Plant Education Details
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Business Administration And Management, General -
Pharmaceutical Sciences
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Physiology, General
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Honours
Frequently Asked Questions about David Plant
What company does David Plant work for?
David Plant works for Csl
What is David Plant's role at the current company?
David Plant's current role is Senior Global Regulatory Lead at CSL.
What is David Plant's email address?
David Plant's email address is da****@****rus.com
What schools did David Plant attend?
David Plant attended Deakin University, University Of Melbourne, University Of Melbourne, University Of Melbourne.
What skills is David Plant known for?
David Plant has skills like Regulatory Affairs, Fda, Clinical Development, Pharmaceuticals, Vaccines, Biotechnology, Tga, Pharmaceutical Industry, Clinical Research, Regulatory Submissions, Drug Development, Pharmacovigilance.
Who are David Plant's colleagues?
David Plant's colleagues are Maria Rosa Troia, Xin L., Brandon Little, Brian Craig, Diem Jones, Victoria Lyons, Greg Boss.
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David Plant
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