Regulatory Affairs Specialist

2 months ago

Sydney, New South Wales, Australia S8 Expert Recruitment Solutions Full time
Regulatory Affairs Manager

We are seeking a highly skilled Regulatory Affairs Manager to join our dynamic team at a global Animal Health Pharmaceutical company. This exciting role will involve managing regulatory affairs, pharmacovigilance, and quality assurance for our Australian and New Zealand operations.

Key Responsibilities:
  • Regulatory Affairs:
    • Oversee and prepare submissions for product registrations and variations in Australia and New Zealand.
    • Manage regulatory submissions in accordance with global and local affiliate plans.
    • Liaise with regulatory authorities and participate in industry activities to influence regulatory policies.
    • Ensure compliance with import permits and license applications.
    • Maintain global product records and manage the regulatory/QA budget.
Pharmacovigilance:
  • Implement and maintain the local Pharmacovigilance system.
  • Collect, record, assess, and report adverse events.
  • Conduct surveillance and evaluation of product safety.
  • Manage deviations and CAPAs.
  • Prepare for and participate in regulatory inspections.
Quality Assurance:
  • Manage all quality assurance matters, including product release and destruction.
Qualifications:
  • Veterinary degree or equivalent science qualification.
  • Ideally 10 years of experience in the animal health industry.
  • Strong understanding of regulatory requirements in Australia and New Zealand.
  • Experience in Regulatory Affairs and understand pharmacovigilance and quality assurance.
  • Excellent communication and interpersonal skills.
  • Proficiency in Microsoft Office Suite.
Benefits:
  • Competitive salary of $130,000 - $150,000 base plus superannuation.
  • Hybrid work arrangement.
  • Opportunity for professional development and growth.
  • Join a global leader in animal health.

  • Senior Regulatory Advisor

    1 month ago

    Sydney, New South Wales, Australia Regulatory Affairs Full time

    Job Title: Senior Regulatory AdvisorJoin our Regulatory Affairs team as a Senior Regulatory Advisor, where you will play a pivotal role in ensuring compliance at The Star. As a key member of our team, you will support the business in understanding their regulatory obligations and assist in progressing business initiatives for approval.About the Role:Maintain...

  • Senior Regulatory Advisor

    1 month ago

    Sydney, New South Wales, Australia Regulatory Affairs Full time

    Job Title: Senior Regulatory AdvisorJoin our Regulatory Affairs team as a Senior Regulatory Advisor and play a pivotal role in ensuring compliance at The Star. As a key member of our team, you will be responsible for supporting the business in understanding their regulatory obligations and assisting in progressing business initiatives for approval.About the...

  • Regulatory Affairs Specialist

    2 months ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Regulatory Affairs SpecialistResMed Inc is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Global Product Regulatory Affairs function, you will be responsible for leading regulatory affairs strategy to ensure compliance with regulatory frameworks and quality systems.Key Responsibilities:Develop and implement...

  • Regulatory Affairs Specialist

    2 months ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ResMed Inc. as a Specialist, Regulatory Postmarket Compliance. This role will be responsible for leading regulatory affairs strategy to ensure compliance with postmarket regulations and quality standards.Key ResponsibilitiesDevelop and implement regulatory postmarket...

  • Regulatory Affairs Specialist

    5 days ago

    Sydney, New South Wales, Australia Novartis Full time

    Regulatory Affairs Role OverviewWe are seeking a highly experienced Regulatory Affairs Specialist to join our team at Novartis. As a key member of our team, you will play a critical role in determining the optimal regulatory pathway to accelerate the approval process.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with...

  • Regulatory Affairs Specialist

    5 days ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    Regulatory Affairs Specialist Position OverviewJohnson & Johnson is currently seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will play a critical role in supporting our business growth by providing regulatory leadership of a portfolio of products.Main Responsibilities:Lead a...

  • Regulatory Affairs Specialist

    3 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    About the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team as a Senior Consultant. As a key member of our Regulatory, Quality & Compliance team, you will be responsible for managing complex regulatory projects for clients in Australia, New Zealand, and the JAPAC region.Key Responsibilities:Develop and implement regulatory...

  • Regulatory Affairs Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Zimmer Biomet Full time

    Unlock Your Potential in Regulatory AffairsAt Zimmer Biomet, we're committed to pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader, we're dedicated to enhancing patient mobility and quality of life. As a Regulatory Affairs Specialist, you'll play a critical role in ensuring our products meet the...

  • Regulatory Affairs Specialist

    6 days ago

    Sydney, New South Wales, Australia PharmaLex Full time

    Regulatory Affairs Role OverviewWe are seeking an experienced Regulatory Affairs Professional to join our Pharmaceutical Regulatory Consulting team in Australia.In this role, you will work with a broad range of clients, predominantly in the pharmaceutical and health care sectors, to ensure licensing, marketing, and regulatory compliance of products.You will...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia Device Technologies Australia Pty Ltd Full time

    About us...At Device Technologies Australia Pty Ltd, we are dedicated to delivering innovative solutions to the healthcare industry. Our commitment to quality, safety, and efficacy is unwavering, and we are seeking a skilled Regulatory Affairs Specialist to join our team.The opportunity...You will be responsible for a portfolio of medical devices, ensuring...

  • Regulatory Affairs Specialist

    6 days ago

    Sydney, New South Wales, Australia Reckitt Benckiser Australia Full time

    We are Reckitt, a global leader in hygiene, health, and nutrition. Our purpose is to protect, heal, and nurture in the relentless pursuit of a cleaner, healthier world.As a Regulatory Affairs Specialist, you will be responsible for shaping the synergy between our innovative products and the regulatory framework that guides them.This role offers the...

  • Regulatory Affairs Director

    2 months ago

    Sydney, New South Wales, Australia ENG Con Full time

    Job Title: Associate Director, Regulatory AffairsWe are seeking an experienced Regulatory Affairs professional to join our team in Australia.About the RoleIn this role, you will be responsible for ensuring the regulatory compliance of client products, advising on licensing and marketing strategies, and managing regulatory submissions and approvals.You will...

  • Regulatory Affairs Director

    1 month ago

    Sydney, New South Wales, Australia ENG Con Full time

    Job Title: Associate Director, Regulatory AffairsWe are seeking an experienced Regulatory Affairs professional to join our team in Australia.About the RoleIn this role, you will be responsible for ensuring the regulatory compliance of client products, advising on licensing and marketing strategies, and managing regulatory submissions and approvals.You will...

  • Regulatory Affairs Director

    3 weeks ago

    Sydney, New South Wales, Australia ENG Con Full time

    About the RoleWe are seeking an experienced Regulatory Affairs professional to join our team in Australia. As an Associate Director, Regulatory Affairs, you will be responsible for maximizing client commercial success by ensuring appropriate licensing, marketing, and regulatory compliance of client products.Your Key ResponsibilitiesAdvise and support clients...

  • Regulatory Affairs Specialist

    1 month ago

    Sydney, New South Wales, Australia S8 Expert Recruitment Solutions Full time

    Regulatory Affairs ManagerA dynamic and experienced Regulatory Affairs Manager is sought to join our team at S8 Expert Recruitment Solutions. This role will involve managing regulatory affairs, pharmacovigilance, and quality assurance for our Australian and New Zealand operations.Key Responsibilities:Regulatory Affairs:Oversee and prepare submissions for...

  • Regulatory Affairs Specialist

    1 month ago

    Sydney, New South Wales, Australia S8 Expert Recruitment Solutions Full time

    Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to join our dynamic team at a global Animal Health Pharmaceutical company. This role will involve managing regulatory affairs, pharmacovigilance, and quality assurance for our Australian and New Zealand operations.Key Responsibilities:Regulatory Affairs:Oversee and prepare...

  • Regulatory Affairs Specialist

    3 weeks ago

    Sydney, New South Wales, Australia S8 Expert Recruitment Solutions Full time

    Regulatory Affairs ManagerA global Animal Health Pharmaceutical company is seeking a dedicated Regulatory Affairs Manager to join their dynamic team. This hybrid role will involve managing regulatory affairs, pharmacovigilance, and quality assurance for our Australian and New Zealand operations.Key Responsibilities:Regulatory Affairs:Oversee and prepare...

  • Regulatory Affairs Specialist

    2 months ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Johnson & Johnson. As a key member of our Regulatory Affairs team, you will play a critical role in supporting the development and submission of regulatory applications for our products in Australia and New Zealand.Key ResponsibilitiesLead a product...

  • Regulatory Affairs Specialist

    4 weeks ago

    Sydney, New South Wales, Australia S8 Expert Recruitment Solutions Full time

    Regulatory Affairs ManagerA dedicated Regulatory Affairs Manager is sought to oversee regulatory affairs, pharmacovigilance, and quality assurance for Australian and New Zealand operations.Key Responsibilities:Regulatory Affairs:Oversee and prepare submissions for product registrations and variations in Australia and New Zealand.Manage regulatory submissions...

  • Regulatory Affairs Specialist

    2 months ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Johnson & Johnson. As a key member of our Regulatory Affairs team, you will play a critical role in supporting the development and submission of regulatory applications for our products in Australia and New Zealand.Key ResponsibilitiesLead a portfolio of...