Regulatory Affairs Director – Veterinary Products (The position has been filled)
Australia, New South Wales
Full Time
21/06/2018
  • Senior Regulatory Role Based in Melbourne or Sydney
  • Utilise your Experience to Set Strategy & Obtain Regulatory Approval for Veterinary Products
  • Permanent Full-time Role with Excellent Salary Package

 

CLIENT

Our client is an exciting and growing Australian business operating in the domestic animal health industry, commercialising new products for the market. Supported by a strong company history in partnerships, innovation and expertise, this is a unique opportunity for a Regulatory Affairs Director to help shape the operating and commercial landscape. With offices in both Melbourne and Sydney, our client offers location flexibility and a salary commensurate for this role.

 

THE ROLE

Reporting directly to the CEO, you will direct and manage the regulation process for products requiring registration with APVMA. You will handle all regulatory interactions and assist in developing procedures to ensure regulatory compliance. Initially, you will be working on the registration of solid orals, injectables, powders and suspensions for companion pets. In time, you will also manage 2-3 R&D projects per year, coordinating and compiling product dossiers, studies and registration applications.

Some key responsibilities include:

  • Develop and implement regulatory strategy for the business to best align with commercial vision.
  • Identify, interpret and communicate Australian regulatory requirements for Product Registration of veterinary medicines.
  • Review product dossiers for document structure and content including SOPs, validation protocols, tech files and project documentation across the Veterinary product area of the business.
  • Co-ordinate and manage Regulatory and Business related projects with internal and external customers.
  • Determine regulatory impact on changes to Product(s) through the Change Control management system.
  • Managing expectations of commercial operations with the expectations of the manufacturing and supply chain.
  • Input into technical content of Project Plans and Risk Assessments.
  • Liaise with QA, regulatory affairs, R&D, production, manufacturing, sales/ marketing in relation to documentation.
  • Prepare documentation for inclusion in Technical Files & Regulatory Submissions.
  • Preparing/Assisting with Technical Reports for Marketing.
  • Maintain up-to-date awareness of Regulatory trends, changes and requirements.
  • Train, assist and collaborate with other staff as required.

 

SELECTION CRITERIA

  • Tertiary qualifications in a relevant Science field, degree as a minimum
  • Post graduate qualifications in a legal field or a business discipline, highly regarded.
  • Several years’ experience working in a technical/regulatory role in the Veterinary industry.
  • Strong knowledge of the APVMA regulatory environment in regards to veterinary medicines
  • Excellent analytical, written and verbal communication and presentation skills.
  • Ability and experience managing regulatory requirements to ensure a cost effective, compliant product is registered in a timely manner.
  • Demonstrated experience and success in Product Registration processes over several years.
  • Managing expectations of commercial operations with the expectations of the manufacturing and supply chain.
  • Demonstrated attention-to-detail, and time management ability.
  • Proven experience using Microsoft Office applications as well as an understanding of styles and the ability to create templates in addition to computer literacy skills with proficiency in standard business software.
  • Ability to work autonomously and in a team.
  • Ability to work across departments.
  • Working and communicating effectively across many countries and cultures.
  • Excellent communication skills, written and oral.
  • Able to prioritize and accommodate competing demands.
  • Clear thinking and sound judgment.
  • Able to use own initiative and drive projects as required.
  • Full working rights in Australia.

 

APPLICATIONS

To apply for this role, click the ‘Apply Now’ button to send your updated resume and a covering letter addressing selection criteria to CS Executive Group.

Alternatively, for a confidential discussion about this role, please call Helen on +61 3 9516 0100 during office hours or 0438 620 434 after hours and on the weekend.

 

THANK YOU

We would like to thank you for taking the time to apply for this role. Unfortunately, due to the large volume of candidates we receive daily, we can only contact those with suitable qualifications and experience. Accordingly, if on this occasion you are not successful in being shortlisted, your resume will remain on our database and be considered for future suitable roles.