Deb Cooper Gaicd Cppp Email and Phone Number
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As a Chief Operating Officer and project management expert, I’m passionate about finding pragmatic solutions to complex problems. With extensive experience in regulatory affairs, therapeutic product development and commercialisation consulting roles, a large proportion of my career has been spent in multinational innovator companies & senior project management roles in Australian and international consultancies.Throughout my career I’ve established a reputation for coordinating large numbers of projects simultaneously; a very broad local and international industry network & extensive experience working in close collaboration with the Department of Health & Therapeutic Goods Administration. At Adjutor Healthcare, I seamlessly switch between managing business operations and delivering a huge range of projects, exceeding our clients' expectations & foreseeing issues in a project & finding creative solutions and workarounds. As a leader I am respected for understanding complicated concepts quickly and translating them into terms others can understand. I have created committed, high performing teams & secured exceptional partnerships. I possess natural strengths in organisation & coordination, excelling in maintaining contact with an extensive network. I can have a laugh even under extreme pressure and always challenge myself to do better. My thirst for knowledge has driven me to gain a number of qualifications including a BSc(Hons) in Industrial Chemistry and a Graduate Diploma in Drug Development, both from UNSW. Building on a strong scientific foundation, I have also invested in softer skills including Training and Assessment and Project Management, including becoming a Certified Practicing Project Professional (CPPP). Most recently I have embarked on the AICD Company Directors Course to build on my experience and continue to promote an innovative culture for sustainable growth.With an attitude of efficiency, integrity, commitment & flexibility, I have consistently demonstrated the ability to work independently of executive management & with strong interpersonal skills I have built effective relationships, influencing decision makers at all levels of industry & government. I invite you to connect.
Adjutor Healthcare Group
View- Website:
- adjutor.com.au
- Employees:
- 5
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Coo - Chief Operating OfficerAdjutor Healthcare Group Jul 2022 - PresentMelbourne, Victoria, AustraliaIn this role I manage business operations and oversee the organisation’s provision of specialist end-to-end development and commercialisation of medicines and medical devices. Responsible for delivering a range of projects I leverage my proven project management skills; a very broad local and international industry network; and extensive experience working in close collaboration with government; in combination with an appreciation of commercial drivers.I work tirelessly to ensure our team provides global healthcare development and commercialisation solutions to our stakeholders.
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Coo And Senior ConsultantAdjutor Healthcare Pty Ltd Jan 2020 - Jul 2022Melbourne, AustraliaIn this role I manage business operations and oversee the organisation’s provision of specialist end-to-end development and commercialisation of medicines and medical devices. Responsible for delivering a range of projects I leverage my proven project management skills; a very broad local and international industry network; and extensive experience working in close collaboration with government; in combination with an appreciation of commercial drivers.I work tirelessly to ensure our team provides global healthcare development and commercialisation solutions to our stakeholders.
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DirectorMaddjamm Pty Ltd Feb 2014 - PresentGeelong Area, AustraliaDealing with the peaks and troughs of the small business world can be challenging. I am an affordable, flexible resource that can provide a diverse range of technical and organisational services to help keep you on track. I aim to provide the support you need, when you need it.Recent projects include:- Grant writing - advanced manufacturing- Small busines start up activities- Business development proposal support - aerospace industry- Regulatory affiars consulting - pharmaceuticals
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Coo And Senior ConsultantTudorrose Consulting Pty Ltd Aug 2019 - Jul 2022Melbourne, AustraliaIn this role I manage business operations and oversee the organisation’s facilitation of the ethical development and commercialisation of products that will enhance patient quality of life.Specialising in prescription medicines (Rx) and Medical Devices, my role involves working with affiliate networks into Asia, Western and Eastern Europe, North, South and Central America, the Middle East and Africa.In addition to a Melbourne, Australia head office we provide a team that is highly experienced in international product development and commercialisation. -
Project LeaderCommercial Eyes Pty Ltd Nov 2017 - Jul 2019Melbourne, AustraliaIn this role I was responsible for client projects, working with internal and client teams. Key areas of focus included managing resources, budgets and timelines for multiple concurrent projects; the provision of strategic advice and support to clients regarding the regulatory environment pertaining to the registration of pharmaceuticals in Australia and New Zealand; reviewing, critically evaluating, preparing and submitting regulatory data to health authorities; business development, including proposal generation incorporating project planning. I operated within the requirements of an ISO 9001 quality management system.Key Achievements:- Developed and improved internal project management systems and tools.- Generation of modular templates for efficient generation of client agreements and responses to requests for proposals and tenders.- Management of increase in department website content and social media presence.- Concurrently managed major projects for 3 separate clients.- Continued to deliver workshops for ARCS ‘An Introduction to Regulatory Affairs in Australia’. -
Senior Manager EducationArcs Australia Ltd Aug 2016 - Nov 2017Sydney, AustraliaIn this role I was responsible for managing, developing, and delivering professional education (including e-learning, conferences and workshops) for specific functions within the pharmaceutical sector.Key areas of focus included leading and advising on financial, resource and stakeholder management; managing expert advisory panels and teams of volunteers; monitoring the external environment and liaising with regulators, other government bodies, industry associations and members to identify education opportunities; managing external education providers via tenders, contract negotiation and ongoing liaison.I was also responsible for contributing to the organisational strategy development and execution for communications, marketing, website content management, membership and partnerships.As Regulatory Affairs Training Manager, I assisted ARCS to deliver on initiatives in professional development, training and member support through the creation, management, delivery of education and other services in Regulatory Affairs, Quality/GMP and Health Economics.Key Achievements: - Promoted to Senior Manager Education (June 2016).- Management of programme structure and content, speakers and chairs for 8 major conferences (up to 100 speakers and 1500 attendees at each conference).- Project management for the tender, contracting, development and launch of 5 new externally facilitated training workshops.- Assisted TGA with delivery of their external communication strategy through workshops, webinars and targeted consultations and provision of advice regarding other TGA activities.- Improvement of organisation communication with external stakeholders via newsletter articles, social media and targeted educational events. The proportion of professionals receiving their first notification of regulatory updates via ARCS increased from 8% to 78% in 3 years.- 20+ deliveries of a 3-day public training workshop – An Introduction to Regulatory Affairs in Australia
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Regulatory Affairs Training ManagerArcs Australia Ltd Apr 2012 - Aug 2016Geelong Area, AustraliaAssisting ARCS to deliver on initiatives in professional development, training and member support through the creation, management, delivery of education and other services in Regulatory Affairs, Quality/GMP and Health Economics.
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DirectorCooper Mcguigan Consulting Pty Ltd (Cmc) Dec 2008 - Apr 2012A consultancy, working with global pharmaceutical clients based in the EU, USA and Australia, offering CMC strategic advice and regulatory support for development programmes and submissions, primarily in the European Union and Australia. Benefitting from close ties and strong working relationships with CMC consultants in the EU and USA, facilitating global collaboration and timely access to additional resources.
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Senior Project ManagerKendle International Nov 2006 - Dec 2008Melbourne, Australia· Project management and co-ordination of Regulatory, Development & Commercialisation activities on behalf of clients, ensuring compliance with relevant legislation and quality standards.· Provision of consulting services to assist clients to develop appropriate regulatory and development strategies.· Management of the Regulatory Service Area - training of Regulatory staff and generation and review of local and international SOPs and advertising material. -
Manager, Cmc Regulatory AffairsGilead Sciences International Sep 2003 - Oct 2006Cambridge, United KingdomIn this role I was responsible for the independent management of all CMC regulatory strategy and activity for the EU and Middle East from April 2004 to October 2005. Subsequently reporting to CMC Associate Director, key areas of focus included the management of the CMC aspects of development products, including provision of strategic advice and writing of Investigational Medicinal Product Dossiers (IMPDs); recruitment and management of 3 employees, 1 administrator and 2 Regulatory Associates; the provision of leadership on submissions teams and other cross functional teams to develop global CMC regulatory and change control policies and strategies. I was also responsible for the maintenance of knowledge of regulatory requirements for the EU and Middle East, communication of changes to guidance within the company and feedback to agencies with company position to influence the regulatory environment. In addition, I factiltated promotion of the company's position within industry through active participation in professional conferences, workshops, and other professional events. -
Senior Regulatory ExecutiveGlaxosmithkline Apr 2001 - Sep 2003Harlow, United KingdomIn this role I was provided global post-approval CMC regulatory support for a large product portfolio registered via national and Mutual Recognition procedures.Key areas of focus included planning, preparation and tracking of marketing authorisation applications, renewals, variations, site transfers and line extensions; recommending regulatory strategies, influencing project direction and assisting in the development of product strategies; negotiating with country offices to deliver innovative strategies to obtain rapid approval; discussing regulatory questions and co-ordinating response documents with various internal departments, local operating groups and their Health Authorities to facilitate approval.I also provided input into proposed EU and International guidelines in order to influence the regulatory environment. -
Registered Technical Details ReviewerGlaxosmithkline Oct 2000 - Apr 2001Ware, United Kingdom· Review of registered manufacturing details for > 20 products against site manufacturing documentation to identify non-compliances.· Development of action plans to address non-compliances via variations or change in site practices.· Creation of internal in-process controls, release and end-of-life specifications.
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Regulatory Affairs & Quality ControlDiametrics Medical Limited Mar 2000 - Aug 2000· Preparation of successful Canadian Device License applications and document packages for Asia/Pacific registrations of medical devices. -
Scientist, Technical & Quality AssuranceJohnson & Johnson Pacific Pty Ltd Oct 1998 - Feb 2000· Applications for registration of OTC drugs, medical devices and new cosmetic ingredients in Australia and medicines in New Zealand.· Development of an ISO 9002 and GMP compliant consumer complaints system & user guide resulting in early recognition / correction of at least 3 major quality issues and increased complaint handling efficiency. -
ScientistJohnson & Johnson Research Pty Ltd Apr 1996 - Oct 1998· Applications for registration of OTC drugs, medical devices and new cosmetic ingredients inAustralia and medicines in New Zealand.· Development of an ISO 9002 and GMP compliant consumer complaints system & user guideresulting in early recognition / correction of at least 3 major quality issues and increasedcomplaint handling efficiency.
Deb Cooper Gaicd Cppp Skills
Deb Cooper Gaicd Cppp Education Details
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Pass With Order Of Merit -
Project Management -
Certificate Iv In Training And Assessment -
Positive Psychology -
Fundamentals Of Project Planning And Management -
The Science Of Medicines -
Know Thyself -
(Advanced) -
Running
Frequently Asked Questions about Deb Cooper Gaicd Cppp
What company does Deb Cooper Gaicd Cppp work for?
Deb Cooper Gaicd Cppp works for Adjutor Healthcare Group
What is Deb Cooper Gaicd Cppp's role at the current company?
Deb Cooper Gaicd Cppp's current role is Adjutor Healthcare COO | Leader | Regulatory Affairs, Development, Commercialisation | Driving life saving and life changing therapeutics for patients.
What is Deb Cooper Gaicd Cppp's email address?
Deb Cooper Gaicd Cppp's email address is co****@****hoo.com
What is Deb Cooper Gaicd Cppp's direct phone number?
Deb Cooper Gaicd Cppp's direct phone number is +614027*****
What schools did Deb Cooper Gaicd Cppp attend?
Deb Cooper Gaicd Cppp attended Australian Institute Of Company Directors, Australian Institute Of Management, The Gordon, Unsw, Unsw, University Of Pennsylvania, University Of Virginia Darden School Of Business, Monash University, University Of Virginia, Newcastle College, Newcastle College.
What are some of Deb Cooper Gaicd Cppp's interests?
Deb Cooper Gaicd Cppp has interest in Children, Environment, Education, Poverty Alleviation, Science And Technology, Health.
What skills is Deb Cooper Gaicd Cppp known for?
Deb Cooper Gaicd Cppp has skills like Regulatory Affairs, Pharmaceutical Industry, Regulatory Requirements, Regulatory Submissions, Quality Assurance, Gmp, Medical Devices, Strategy, Pharmaceutics, Change Control, Drug Development, Training.
Who are Deb Cooper Gaicd Cppp's colleagues?
Deb Cooper Gaicd Cppp's colleagues are Tanya Mercier, Kaysia Wilson, Martie Van Heerden, Kelley Wilson, Kate Burke, Vasile Cobuz, David Batka, Phd.
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