Regulatory Affairs Manager, Australia Animal Health

1 week ago

Macquarie Park, Australia MSD Full time

Regulatory Affairs Manager | Animal Health
-
Permanent Full-time position with
competitive renumeration and
benefits
-
Based: AUS
New South Wales Macquarie Park Join a growing, yet already
successful business-
Upskill and growth in an area your passionate about, whilst being fully supported and encouraged.

  • Join a
    Trusted Global Leading organisation


The primary responsibility of the Regulatory Manager, Australia (Animal Health) is to drive the development, importation, and registration of new products in Australia to ensure internal and external regulatory compliance for the entire product range.


This role will lead a small team supporting new product development and registration projects and for conducting routine regulatory operations to ensure compliance.

The role reports to ANZ Lead Regulatory Affairs and Pharmacovigilance.

Our company operates in a highly regulated and very competitive environment. Success is often dependent on getting new products into the market quickly.

This requires a high level of coordination between the regulatory team, R&D, global regulatory functions, sales and marketing and includes other internal stakeholders and the regulators.


What You Will Do

Regulatory Project Management and Leadership

  • Lead and coordinate the Regulatory Affairs, Australia (Animal Health) team in pharmaceutical, biological and other relevant sectors to deliver new product registrations and line extensions and associated approvals (biosecurity, OGTR) in accordance with agreed timelines and government, industry and corporate requirements to facilitate rapid supply of new products.
  • Planning, track, report, allocate resources and budget for projects.
  • Effectively scope, assign tasks and allocate resources for meeting goals within project budget.
  • Proactively review and modify project(s) for threats and opportunities and manage known risks.
  • Support the development of the regulatory strategy for new technologies across ANZ. Leveraging complex knowledge of the global/regional/local regulatory landscape, precedents, and competitive intelligence to identify key business opportunities. This will include liaising with internal stakeholders (GRA, Commercial, Technical) and regulatory authorities with the view of gaining market access for these new technologies.
  • Leadership support for internal processes, including Change Controls, to ensure that our Company's products comply with the regulatory and legal requirements set by the local authorities.
  • Lead or support PQC investigations and recall actions, as required.
  • Able to advise or coach others on:
  • effectively structuring documentation and regulatory/risk communications and identifying document templates and standards,
- project management and task completion.
- use of problem-solving tools and techniques encouraging others to think creatively to achieve new solutions.

  • Maintain relationships and lead discussions or initiatives, as required, with the regulators and industry bodies (AMA).

General

  • Provide regulatory and technical advice as requested to other parts of the organization to ensure that correct and compliant information is used in decision making and strategy development.
  • Ensure all advertising, promotional and educational/technical materials that are related to products marketed comply with applicable local laws and regulations and consistent with all corporate and our company's Animal Health's policies, standards and reflects our company's Code of Conduct.
  • Actively collect, analyse and disseminate regulatory intelligence and other information in accordance with commercial interests.
  • Effectively participate in Regulatory team discussions, bringing forward issues for consideration and contributing to the development of solutions and strategies.
  • Ensure good housekeeping in the work area in accordance with company and relevant quality standards.
  • Identify and mitigate business risks of noncompliance and leads creation of solutions to drive high quality and compliant work products.
  • Identify and integrate patterns, trends, and inconsistencies across multiple data sources to determine their broader implications
What You Must Have

  • Graduate or Post-Graduate degree in a relevant biological science.
  • Extensive experience in Animal Health or a related industry; ideally coupled with solid experience in leading regulatory projects and / or teams.
  • Knowledge and understanding of local regulations, policies and guidelines related to drug development, regulatory file submission, pharmacovigilance and drug promotion.
  • Highly developed skills in negotiating, influencing, leadership with regulatory bodies and other relevant internal and external stakeholders.
  • Excellent communication, presentation and organizational skills, with demonstrated ability to articulate complex thoughts and ideas accurately and clearly.
  • Thorough working understanding of quality systems.
  • Logica

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