Kristen Perry

Kristen Perry Email and Phone Number

Senior Regulatory Affairs Manager at Pfizer @ Pfizer
new york, new york, united states
Kristen Perry's Location
Sydney, New South Wales, Australia, Australia
Kristen Perry's Contact Details

Kristen Perry personal email

About Kristen Perry

Kristen Perry is a Senior Regulatory Affairs Manager at Pfizer at Pfizer. She possess expertise in research, pharmaceutical industry, life sciences, hplc, science and 40 more skills.

Kristen Perry's Current Company Details
Pfizer

Pfizer

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Senior Regulatory Affairs Manager at Pfizer
new york, new york, united states
Website:
pfizer.com
Employees:
112906
Kristen Perry Work Experience Details
  • Pfizer
    Senior Regulatory Affairs Manager
    Pfizer Jan 2022 - Present
    Sydney, New South Wales, Australia
    Lead and manage a team of Regulatory Affairs professionals to ensure successful regulatory submissions and approvals for designated product portfolios, in line with strategic/business goals and health authority requirements.Ensure that post marketing activities, including all relevant compliance activities are completed for assigned portfolios.Support the Head of Regulatory Affairs to lead and manage the strategic direction, operational and financial performance of the Regulatory Affairs Department for the business in Australia and New Zealand.
  • Pfizer
    Regulatory Affairs Manager
    Pfizer Jan 2021 - Present
    Sydney, New South Wales, Australia
    Lead and manage a team of Regulatory Affairs professionals to ensure successful regulatory submissions and approvals for designated product portfolios, in line with strategic/business goals and health authority requirements.Ensure that post marketing activities, including all relevant compliance activities are completed for assigned portfolios.Support the Head of Regulatory Affairs to lead and manage the strategic direction, operational and financial performance of the Regulatory Affairs Department for the business in Australia and New Zealand.
  • Pfizer
    Senior Regulatory Affairs Associate
    Pfizer Jul 2019 - Jan 2021
    Sydney, Australia
    • Ensure NMEs and line extensions are approved within timelines defined by the Pfizer Australia/New Zealand Operating and Strategic Plans consistent with Health Authority processes. • Ensure maintenance of in line products on the market by carrying out all regulatory activities associated with change control processes for labelling, CMC and artwork. • Ensure maintenance of in line product on the market by carrying out all product defence regulatory activities for product defence.• Represent Regulatory Affairs Department on relevant Pfizer Australia brand/project teams to:• Lead activities to develop regulatory strategies for NMEs, product enhancements, and product defence• Provide regulatory advice to Pfizer Australia and Worldwide Development partners to assist with good business decision making• Take accountability and work collaboratively with the relevant development functions, including building productive relationships with EU Regulatory Leads and support teams to ensure delivery of submission ready, approvable dossiers• Manage product submission/approval process with Regulators and Development Partners to deliver best outcomes for Pfizer• Scan regulatory environment, identify and assess the impact of new/emerging guidelines for Regulatory, Pfizer Australia and the wider Pfizer Organisation• Manage interactions with Regulators and build productive collaborative relationships with relevant TGA/Medsafe personnel and International Regulatory Leads• Build productive collaborative relationships with relevant Global Regulatory Leads• Where needed, lead Departmental initiatives and/or project teams• Where needed, assist with the development of less experienced staff• Effective communication with Manager on regulatory actions, decisions or strategies.
  • Pfizer
    Regulatory Affairs Associate
    Pfizer Jan 2016 - Jan 2021
  • Pfizer
    Graduate Regulatory Affairs Associate
    Pfizer Jan 2014 - Dec 2015
  • The University Of Sydney
    Casual Academic
    The University Of Sydney Jun 2012 - Oct 2013
    Undergraduate Laboratory Demonstrator

Kristen Perry Skills

Research Pharmaceutical Industry Life Sciences Hplc Science Chemistry Pharmacology Sop Standard Operating Procedure Regulatory Affairs Regulatory Submissions High Performance Liquid Chromatography Capa Gmp Fda Validation Quality System Change Control Quality Assurance 21 Cfr Part 11 Quality Auditing Cross Functional Team Leadership Medical Devices Quality Control Aseptic Processing Manufacturing Corrective And Preventive Action Continuous Improvement Iso 13485 Lean Manufacturing Six Sigma Process Improvement Root Cause Analysis Biotechnology Computer System Validation Design Control Fda Gmp Technology Transfer U.s. Food And Drug Administration Cleaning Validation Fmea Software Documentation Trackwise Gxp Business Process Improvement

Kristen Perry Education Details

  • The University Of Sydney
    The University Of Sydney
    Honours I

Frequently Asked Questions about Kristen Perry

What company does Kristen Perry work for?

Kristen Perry works for Pfizer

What is Kristen Perry's role at the current company?

Kristen Perry's current role is Senior Regulatory Affairs Manager at Pfizer.

What is Kristen Perry's email address?

Kristen Perry's email address is kr****@****ira.com

What schools did Kristen Perry attend?

Kristen Perry attended The University Of Sydney.

What skills is Kristen Perry known for?

Kristen Perry has skills like Research, Pharmaceutical Industry, Life Sciences, Hplc, Science, Chemistry, Pharmacology, Sop, Standard Operating Procedure, Regulatory Affairs, Regulatory Submissions, High Performance Liquid Chromatography.

Who are Kristen Perry's colleagues?

Kristen Perry's colleagues are Yaniel Martinez, Rich Bulwicz, Carlene Duncan, Allan Sessoms,jr, Mary Murphy, Axel Rivera, Jamie Moore.

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