Penny Cain
Nationality: Australian
Education
Bachelor of Veterinary Science (Hons) University of Sydney
Graduate Diploma of Veterinary Public Health Management, University of Sydney (focusing on project management and veterinary epidemiology).
Bachelor of Fine Arts, Australian National University
Master of Fine Arts (creative arts), University of Sydney (2016)
Relevant employment history
ROLES AND RESPONSIBILITIES
Veterinary Clinician, VMRD, Zoetis Animal Health Sydney Jan 2017- June2018
Clinical management of allocated new vaccine development projects: responsible for bringing my portfolio of new products from Discovery to Research & Development phase and through to registration dossier preparation. This included:
Developing the project plan and budget for each product. Regular reporting financially and scientifically to senior management locally and globally.
Sponsoring individual studies. This included:
Preparation of individual study protocols, sourcing and contracting CROs, Animal Ethics Committee applications, management of VCRA (veterinary clinical research associate) allocated to the study. Most studies conducted to VICH-GCP (light); per APVMA.
Preparation of study reports (solo or with CRO) and input to registration dossier.
Communication with regulators (APVMA, Department of Agriculture) in writing and meetings to ensure study program met requirements, and present arguments for modifications and waivers where appropriate.
Other:
Technical literature reviews for internal and external stakeholders.
Panel member to evaluate and rank local new development proposals.
Collaboration with Commercial technical team to develop a production animal drug delivery strategy.
Regulatory Affairs Specialist, MSD Animal Health Jan 2005 – Nov 2016
Project managed numerous successful registration projects for veterinary vaccines. This included APVMA registration and Department of Agriculture import permit applications. Of these I managed more than 10 to projection completion with importation and registration.
For local development projects I had technical input to the design and regulatory oversight of local efficacy, safety and stability studies undertaken by R&D, and prepared complete registration dossiers.
For global projects, with a global registration package, I evaluated these for data gaps against Australian regulatory requirements (APVMA and Department of Agriculture), and prepared relevant technical arguments and sections of the registration dossiers.
Oversaw local or overseas studies to meet additional Australian regulatory requirements, such as local efficacy and additional stability data.
Preparation of import permit dossiers for imported finished vaccines and seed material, including:
Undertaking technical literature reviews, and
Providing input and oversight of studies to generate new data to meet Department of Agriculture extraneous agent concerns. This included seed and raw material extraneous agent testing, process validation and inactivation kinetics studies.
Preparation of technical responses to requests for further information from regulators. These were based on literature reviews and leveraged my:
extensive knowledge of vaccine development and manufacture
veterinary background
prior experience from working in both DOA/ AQIS and APVMA, and
capacity to liaise with the manufacture site and relevant in-house global technical experts. If required I located and contracted external experts for independent opinion.
Preparation of applications to Department of Agriculture for in-vivo use of biological raw materials, for use at MSD’s Bendigo manufacture facility.
Assisted with resolution of any Department of Agriculture Approved Premises audit findings. In this I drew on my knowledge of vaccine manufacture and regulatory requirements, auditing experience, and experience with meeting regulators’ expectations.
Liaison with the OGTR for imported finished vaccines of genetically modified origin as required.
Provided advice to MSD’s global regulatory affairs on local regulatory policy and legislation.
Based on my extensive industry experience I have an in-depth understanding of legislation and regulatory requirements of the APVMA and Department of Agriculture. In addition, I have a very sound understanding of 9CFR, EMEA and GMP requirements in relation to veterinary vaccines.
I have a demonstrated ability to manage highly technical vaccine projects at an exceptional level and have extensive experience working collaboratively with all key stakeholders including regulators, local and overseas colleagues, external providers and technical experts to strive for quality result in efficient timelines.
Senior Veterinary Officer, Australian Quarantine and Inspection Service (AQIS), Department of Agriculture, Canberra 1999 – 2004
Assessed many applications for importation of biological materials, including:
finished live and inactivated veterinary vaccines,
bulk antigens,
animal and plant origin raw materials, and
vaccine seed materials.
Evaluated applications for in-vivo use of biological materials;
Provided technical advice to Approved Premises auditors.
Conducted targeted audits of 6 vaccine manufacture sites and 2 stock food manufacture sites against the relevant AQIS policies, in Australia and overseas. Undertook information-only tours of 4 vaccine manufacture sites.
Drawing on my considerable experience as a senior technical lead, provided scientific and technical advice to team members and other areas within the Department of Primary Industries, and was a member of the relevant Department – Industry liaison committees.
Veterinary Officer Product Manager, Australian Pesticides and Veterinary Medicines Authority (NRA) 1995 – 1996
Assessed multiple applications for registration of new veterinary medicines and amendments to existing registered products.
Prior to this I worked in mixed and small animal practices in NSW and Victoria.
ADDITIONAL INFORMATION
I am a confident user of Microsoft word, Powerpoint, Excel and Microsoft Project on Mac and PC. I also use assorted photo editing and video editing software.
I enjoy stretching myself and for many years have worked in both the scientific and creative spheres. In my Master of Fine Arts I prepared a body of artwork, researched and wrote a 14,000 word thesis, so I have significant experience in thinking creatively and working inter-disciplinarily in addition to writing and communicating clearly.