Fiona Seddon work email
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Fiona Seddon personal email
I am a Regulatory Affairs Professional with a track record in leading cross functional teams to facilitate achievement of business goals. I have broad experience in developing and implementing regulatory strategy and compliance in the pharmaceutical and biotechnology industries, for product development through to lifecycle management for regulatory approvals in Australia, New Zealand, US and EU.
Justpartnering
View- Website:
- justpartnering.com
- Employees:
- 4
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Regulatory ConsultantJustpartneringMelbourne, Vic, Au
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ConsultantJustpartnering May 2023 - PresentMelbourne, AustraliaSpecialising in aligning early preclinical and clinical development plans with regulatory requirements, and product analytics.
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PrincipalRegulatory Resources Dec 2015 - PresentMelbourne, AustraliaProviding - global regulatory affairs strategy and project management to the biotechnology, biopharmaceutical and pharmaceutical industries, expediting the development and commercialisation of products. - technical and scientific writing for preparation of supporting documentation and regulatory submissions. - Development and execution of product characterisation and technology transfer programs
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Associate Director, Regulatory Affairs At Biointelect Pty LtdBiointelect Pty Ltd Apr 2022 - May 2023Melbourne, Victoria, Australia -
Senior Manager Regulatory AffairsBiointelect Pty Ltd Apr 2021 - Aug 2022Melbourne, Victoria, AustraliaCommercialisation of research through efficient incorporation of regulatory science and strategy for biotechnology, biopharmaceutical and pharmaceutical products and medical devices. Building regulatory compliance from the ground up to maximise value for due diligence and commercialisation.
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Senior ConsultantPharmout Jun 2014 - Nov 2015MelbourneRegulatory strategy, compliance gap analysis and preparation of TGA applications to support clients achieve regulatory compliance and approvals.Technical writing to support compliance and efficiency. -
Principal Associate, Regulatory Affairs - Pandemic VaccinesBiocsl 2012 - 2014Parkville, AustraliaManagement of regulatory projects for Pandemic Vaccine product portfolio to achieve successful regulatory outcomes. Preparation and submission of regulatory applications to TGA, Medsafe and FDA. Meetings and negotiation with TGA, Medsafe and FDA. Close collaboration with company's Manufacturing, Commercial Quality and Project Management functions, and companies collaborating on new product opportunities. -
Principal Regulatory Affairs Associate - Regulatory IntelligenceCsl 2009 - 2012Parkville, AustraliaEstablishment of the Regulatory Intelligence function within the Research and Development Regulatory Affairs Department, training for Regulatory Affairs department and support for product development .
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Senior Regulatory Affairs Associate - Product DevelopmentCsl 2001 - 2009Parkville, AustraliaManagement of Master File preparation for a novel adjuvant and team leader for submission of the Master File to United States Food and Drug Administration and German Paul-Ehrlich-Institut.Responsible for ISCOMATRIX® Adjuvant Technology regulatory affairs; development of departmental processes, strategies, and policies; training and supervision of Regulatory Affairs Associates.Leader of Adjuvant Characterisation Team managing development of specifications, reference materials, characterisation and stability to support development of the adjuvant through manufacturing development, scale up and technology transfer.
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Regulatory Affairs Associate - In Licensed ProductsCsl 1997 - 2000Parkville, AustraliaResponsible for maintaining regulatory compliance for in licensed and CSL manufactured vaccines in Australia and New Zealand.
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Regulatory Affairs AssociateCsl 1994 - 1996Parkville, AustraliaPreparation of clinical trial applications for Australia and New Zealand.
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Protein ChemistCsl Limited 1988 - 1994Development of methods for purification, stabilisation and analysis of proteins.
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Research BiochemistMonash University Biochemistry Department Jan 1987 - Sep 1988Clayton, Vic
Fiona Seddon Skills
Fiona Seddon Education Details
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Clinical Chemistry -
Biochemistry And Microbiology
Frequently Asked Questions about Fiona Seddon
What company does Fiona Seddon work for?
Fiona Seddon works for Justpartnering
What is Fiona Seddon's role at the current company?
Fiona Seddon's current role is Regulatory Consultant.
What is Fiona Seddon's email address?
Fiona Seddon's email address is fi****@****.com.au
What schools did Fiona Seddon attend?
Fiona Seddon attended The University Of Western Australia, University Of Melbourne.
What skills is Fiona Seddon known for?
Fiona Seddon has skills like Regulatory Affairs, Pharmaceutical Industry, Regulatory Submissions, Fda, Drug Development, Strategy, Technology Transfer, Biopharmaceuticals, Vaccines, Clinical Trials, Protein Chemistry, Assay Development.
Who are Fiona Seddon's colleagues?
Fiona Seddon's colleagues are Peter Kelly.
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