Michael Pearce Email & Phone Number

Sydney, Australia

Rutherford, Nsw, Australia

Leading the regulatory management of innovative and generic animal health products developed in-house for registration in Australia, New Zealand, Europe, North America and other global markets. Responsible for ensuring new product registrations are submitted in each major market to support a pipeline of new products in these markets. Represent Jurox during interactions with government regulators as well as actively participate in an industry association working group.Collaborated with R&D leaders for Product Development (In-Life) and Chemistry to develop a stage gate new product development process and a new product development pipeline for major stakeholders and global regions.Collaborating with Quality, R&D and Manufacturing to project manage the development and launch of new products. Developed and led a continuous improvement forum for evaluating and implementing improvements to existing products and processes. Coaching regulatory and technical colleagues in the development and regulatory management of animal health products.

Rutherford, Australia

Responsible for the registration and regulatory management of innovative and generic Animal Health products for Europe & North America.Prepared and managed the registration of new products in Australia and UK. Successfully registered a generic sterile injectable analgesic in the UK.Collaborated with R&D leaders in Product Development (In-Life) and Chemistry to improve new product development procedures.Prepared a Drug Master File for an active substance manufactured by Jurox and obtained feedback from experts in UK and USA.

Sydney, Australia

Managing own business to provide R&D, Technical and Regulatory management services to Pharmaceutical industry.Provided business and technical expertise to J&J Asia-Pacific OTC R&D department (Shanghai & Mumbai). # Coaching and mentoring R&D Scientists in Shanghai & Mumbai in the development of new OTC products for the region. # Developed global process and format for technical dossiers used to support the launch of new and changed OTC products globally by J&J Consumer business unit. # Provided significant leadership and technical support to enable the development and launch of new cough liquids in India & Australia. # Improved efficiency and robustness of governance process for OTC products in Asia-Pacific region through developing procedures, templates and management tools. Provided regulatory management and technical expertise to J&J Pacific (Sydney) for OTC cough, cold and allergy brands marketed in Australia and New Zealand. # Managed regulatory submissions for new and changed Benadryl & Zyrtec products # Developed comprehensive rationale to overcome significant umbrella branding regulatory issues with the registration of new allergy products for Australia. # Conducted regulatory compliance investigations and completed remediation activities to align J&J products and their registered details with current regulatory requirements

Sydney, Australia

Coached Thai colleagues in GMP principles and Australian regulatory requirements for analytical, process development and quality systems. Provided expert advice on quality system improvements. This support directly facilitated the successful TGA audit of a previously Cosmetic standard facility and the rapid commercialisation of numerous therapeutic mouthwash products at a contract manufacturing facility in Thailand.Developed collaborative and trusting relationships with key Thai colleagues based on respect, empathy and cultural awareness.Led the process validation and technical development of therapeutic mouthwash products at a contract manufacturer in Thailand and the development of supporting GMP documents and quality systems to enable the commercial supply of these products to Asia-Pacific markets.

Sydney, Australia

Led the investigation and evaluation of potential new OTC products to support the business objectives in Australian and New Zealand.Managed the commercial negotiation with an international contract manufacturer to negotiate access to the technical data package and provide the basis for a subsequent commercial supply agreement.

Sydney Area, Australia

Continuation of previous role at Pfizer Consumer Healthcare under new company name due to acquisition by Johnson & Johnson. J&J transferred the role overseas in May 2008.

Sydney, Australia

Managed up to 4 analytical, product development and documentation colleagues. Responsible for hiring, training, motivation, performance management and professional development of these colleagues.Managed the analytical, formulation and process development and colleagues working in these roles during the development of numerous solid dose products for the Sudafed, Codral, Sinutab and Actifed brands which had gross sales of approx. AU$44 million in 2006 and represented 45% of new product sales for the year.Project managed and led the successful development of numerous Phenylephrine HCl solid dose products that were first to market in Australia and the United States. The Australian Codral franchise increased from AU$24 to AU$37 million over two years as a direct result of the launch of these products.Project managed and led the successful development of new regulated non-prescription products for Australia, Europe, North America, Africa and Asia-Pacific markets.

Sydney, Australia

■ Design and supervison of process development studies including the manufacture of development and validation batches in commercial GMP facilities.■ Stability testing of new solid and liquid products.■ Analytical method development and validation.■ Preparation of Instruction and Qualification documents for new and existing equipment.

Sydney, Australia

Performed raw material and finished product testing using wet chemistry and instrumental techniques to support commercial release of batches of non-prescription products.

Sydney, Australia

■ Formulation and development of new products.■ Preparation of reports, protocols etc to support new product development.■ Development of manufacturing procedures for and supervision of trial batches in production environment.

Mba, Project Management, International Business

Msc (Hons), Environmental Toxicology

Bsc (Hons), Chemistry

Bsc, Chemistry, Ecology