Senior Regulatory Affairs Associate

4 weeks ago


Sydney, New South Wales, Australia Astra Zeneca Full time

AstraZeneca is a global biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines for serious diseases. We are seeking a Senior Regulatory Affairs Associate to join our team in Australia and New Zealand.

About the Role

This is an exciting opportunity for an experienced pharmaceutical regulatory affairs professional to contribute to the development of business strategic and tactical plans. As a Senior Regulatory Affairs Associate, you will provide regulatory input to the development of business plans and deliver effective and commercially advantageous regulatory plans for product submissions.

Key Responsibilities

  • Prepare and execute regulatory submission plans and implement the agreed regulatory strategy to register and maintain products across a range of therapeutic areas.
  • Provide regulatory input to the development of business strategic and tactical plans.
  • Deliver effective and commercially advantageous regulatory plans for product submissions.

Requirements

  • Science related Tertiary qualifications.
  • Experience in a (Senior) Regulatory Affairs role from within the pharmaceutical industry in Australia/New Zealand.
  • Experience preparing category 1 applications.
  • Working relationships with the TGA and/or Medsafe and other relevant government agencies.

What We Offer

AstraZeneca is committed to being a Great Place to Work. We offer a collaborative and inclusive work environment, opportunities for professional growth and development, and a competitive compensation package.

How to Apply

If you are a motivated and experienced regulatory affairs professional looking for a new challenge, please submit your application, including your resume and a cover letter, to our careers page.



  • Sydney, New South Wales, Australia Astra Zeneca Full time

    About the RoleAs a Senior Regulatory Affairs Associate at AstraZeneca, you will play a key role in preparing and executing regulatory submission plans to register and maintain products across various therapeutic areas in Australia and New Zealand. You will demonstrate in-depth knowledge of regulatory affairs submissions and contribute to business improvement...


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

    About the RoleJohnson & Johnson is seeking a highly skilled Senior Regulatory Affairs Associate to join their team. As a key member of the Regulatory Affairs team, you will be responsible for providing regulatory leadership and support for a portfolio of products.Key Responsibilities* Lead a product portfolio to plan regulatory strategies and manage local...


  • 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 RoleThis is an exciting opportunity to work with a leading service company for the Pharmaceutical Industry globally. As an Associate Director, Regulatory Affairs, you will be responsible for maximizing client...


  • Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    Stryker Australia Pty Ltd: Senior Regulatory Affairs Associate PositionWe are seeking a highly skilled Senior Regulatory Affairs Associate to join our high-performing regulatory team in Australia. The successful candidate will bring extensive experience in Regulatory Affairs, Class III and TGA conformity assessment applications, and a strong understanding of...


  • Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    We are seeking a highly skilled Senior Regulatory Affairs Associate to join our high-performing regulatory team at Stryker Australia Pty Ltd.The ideal candidate will have at least 5 years of experience in Regulatory Affairs, with a strong background in Class III and TGA conformity assessment applications.Responsibilities will include preparing and submitting...


  • Sydney, New South Wales, Australia ENG Con Full time

    We are a leading provider of pharmaceutical regulatory consulting services, and we are seeking an experienced Senior Regulatory Affairs Director to join our team in Sydney, Australia.As a Senior Regulatory Affairs Director, you will play a critical role in ensuring the successful registration and approval of our clients' products in the Australian...


  • Sydney, New South Wales, Australia PharmaLex Full time

    Your RoleWe have an opportunity for an experienced Regulatory Professional to join our team in Australia. As a Seasoned Regulatory Affairs Specialist, you will be responsible for ensuring the compliance of products with regulatory requirements. Your primary objective is to maximize commercial success by advising clients on licensing, marketing, and...


  • Sydney, New South Wales, Australia Stryker Australia Pty Ltd Full time

    We are seeking a highly skilled Senior Regulatory Affairs Associate to join our high-performing regulatory team at Stryker Australia Pty Ltd.The ideal candidate will have at least 5 years of experience in Regulatory Affairs, with a strong background in Class III and TGA conformity assessment applications.This role requires a strategic thinker who can thrive...


  • Sydney, New South Wales, Australia ENG Con Full time

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


  • Sydney, New South Wales, Australia ENG Con Full time

    Company OverviewWe are a leading consulting company, specialized in regulatory affairs for the pharmaceutical industry. Our team of experts has extensive experience in all aspects of drug and medical device approval.SalaryThe estimated salary for this position is AU$140,000 - AU$180,000 per year, depending on experience. We offer a range of flexible working...


  • Sydney, New South Wales, Australia Ethos BeathChapman Full time

    Senior Manager Regulatory AffairsEthos BeathChapman is seeking an accomplished professional to join their Regulatory Affairs team. This role offers the chance to contribute to regulatory strategy, build relationships with key regulators, and provide strategic insights to senior leadership.The Role:Drive effective decision-making by leveraging relationships...


  • Sydney, New South Wales, Australia Novartis Full time

    About the Role:As a Regulatory Affairs Manager at Novartis, you will play a crucial role in managing, planning, and coordinating submissions to health authorities in Australia and New Zealand. Reporting to the Head of Regulatory Affairs, you will develop strategies to deliver optimal regulatory outcomes, ensuring compliance with all local laws, regulations,...


  • Sydney, New South Wales, Australia PharmaLex Full time

    About the Opportunity We are seeking an experienced Regulatory Professional to join our Pharmaceutical Regulatory Consulting team in Australia. This role will involve working with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors. Your primary objective will be to maximize client commercial success by ensuring appropriate...


  • Sydney, New South Wales, Australia Novartis Full time

    SummaryInternal Role Title: Regulatory Affairs ManagerLocation: Sydney, AustraliaAbout the Role:As a Regulatory Affairs Manager at Novartis, you will be responsible for managing, planning, and coordinating submissions to health authorities in Australia and New Zealand. You will report to the Head of Regulatory Affairs and develop strategies to deliver...


  • Sydney, New South Wales, Australia Ethos BeathChapman Full time

    Senior Manager - Group Regulatory AffairsEthos BeathChapman is seeking an accomplished professional to join their Regulatory Affairs team. This role offers the chance to contribute to regulatory strategy, build relationships with key regulators, and provide strategic insights to senior leadership.The Role:As a Senior Manager in Group Regulatory Affairs, you...


  • Sydney, New South Wales, Australia Ethos BeathChapman Full time

    Senior Manager - Group Regulatory AffairsEthos BeathChapman is seeking a seasoned professional to lead their Regulatory Affairs team. This is an exceptional opportunity to contribute to regulatory strategy, build relationships with key regulators, and provide strategic insights to senior leadership.The Role:As a Senior Manager in Group Regulatory Affairs,...


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

    Company OverviewJanssen, a part of Johnson & Johnson, is a global healthcare leader driven by a dedication to innovation and customer focus.Job SummaryWe are seeking an experienced Regulatory Affairs Project Manager or Senior Regulatory Affairs Associate to join our team in North Ryde (open to other states). As a key member of the Regulatory Affairs team,...


  • Sydney, New South Wales, Australia Astra Zeneca Full time

    AstraZeneca is a global biopharmaceutical company committed to discovering, developing, and commercializing prescription medicines for serious diseases. We're seeking a Senior Regulatory Affairs Associate to join our Regulatory Affairs team, which is gearing up for an exciting year with major product submissions across various therapy areas.This role...


  • 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...


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

    At Device Technologies Australia Pty Ltd, we are driven by a vision to improve patients' lives through innovative medical solutions.We are seeking a highly skilled Regulatory Affairs Associate to join our team in Sydney. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with local requirements and regulations for...