Experience

Martin & Pleasance

• Australia
• Health, Wellness & Fitness
• 1 - 100 Employee

• Regulatory Affairs Manager

  • Feb 2012 - Present

  Martin & Pleasance offers a portfolio of complementary medicines and nutrition supplements. The position offers support for all aspects of regulatory compliance, product advertising compliance and quality systems support for local and global markets. Working closely with the marketing team this position reports directly to the Managing Director. Martin & Pleasance offers a portfolio of complementary medicines and nutrition supplements. The position offers support for all aspects of regulatory compliance, product advertising compliance and quality systems support for local and global markets. Working closely with the marketing team this position reports directly to the Managing Director.



BioNovelle

• Principal Consultant, Business Owner

  • Jan 2010 - Present

  BioNovelle offers a personal service on matters related to regulatory affairs, compliance and quality systems across a broad range of product specialties. Principal regulatory affairs consultant to a globally distributed (Australian developed) cosmetic brand for a number of years. BioNovelle offers a personal service on matters related to regulatory affairs, compliance and quality systems across a broad range of product specialties. Principal regulatory affairs consultant to a globally distributed (Australian developed) cosmetic brand for a number of years.



Nutrition Systems

• Australia
• Wellness and Fitness Services
• 1 - 100 Employee

• Regulatory & Compliance Manager

  • Nov 2008 - Dec 2010

  Responsible for regulatory and compliance matters for local and international compliance of product portfolio including overseas import requirements. Responsible for regulatory and compliance matters for local and international compliance of product portfolio including overseas import requirements.



Stirling Products Ltd.

• Australia
• Pharmaceutical Manufacturing

• Regulatory Affairs & QA Manager

  • May 2008 - Dec 2008

  Start up company focused on novel treatments for animal health, the role included review of clinical protocols against data and regulatory and compliance matters as they pertain to a company at the commencement of its regulatory and quality systems lifecycle. An ASX listed company the position reported directly to the CEO. Start up company focused on novel treatments for animal health, the role included review of clinical protocols against data and regulatory and compliance matters as they pertain to a company at the commencement of its regulatory and quality systems lifecycle. An ASX listed company the position reported directly to the CEO.



PharmAust Manufacturing Pty., Ltd.

• Australia
• Renewable Energy Semiconductor Manufacturing
• 1 - 100 Employee

• Regulatory Manager

  • Aug 2006 - Oct 2008

  Non-sterile contract manufacturing facility for various listed, over the counter and some licensed in registered goods. Responsible for all regulatory matters on site. The position reported directly to the CEO. Non-sterile contract manufacturing facility for various listed, over the counter and some licensed in registered goods. Responsible for all regulatory matters on site. The position reported directly to the CEO.



INO Therapeutics LLC

• Contract Regulatory Consultant

  • Dec 2006 - Feb 2007

  Offered advice towards obtaining sponsorship and regulatory compliance that would facilitate the distribution of a medical device used for gas delivery systems in support of newborn (neonate) health needs. Representing my own consultancy business BioNovelle. Offered advice towards obtaining sponsorship and regulatory compliance that would facilitate the distribution of a medical device used for gas delivery systems in support of newborn (neonate) health needs. Representing my own consultancy business BioNovelle.



CooperVision

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• QA & Regulatory Affairs Manager

  • Aug 2004 - Jun 2006

  Acted as TGA Quality site representative on site licence. Responsible for all regulatory affairs matters for Class I and Class II medical devices. Global market covering Australia, US, Canada and Europe. Technical file used as an example for teaching others by notified body. The position reported to the Operational Site Leader. Acted as TGA Quality site representative on site licence. Responsible for all regulatory affairs matters for Class I and Class II medical devices. Global market covering Australia, US, Canada and Europe. Technical file used as an example for teaching others by notified body. The position reported to the Operational Site Leader.