Regulatory Affairs Specialist

2 days ago

North Sydney Council, Australia Novo Nordisk AS Full time
Role Summary

We are seeking a highly skilled Regulatory Affairs Specialist to join our Clinical, Medical, Regulatory (CMR) Oceania team. As a Senior Regulatory Affairs Associate, you will lead regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while developing strategies to assist product development, registration, and commercialisation.

About the Department

The CMR Oceania team is responsible for leading regulatory affairs activities for new products and product amendments. We work closely with health authorities and policymakers to shape future regulatory frameworks and ensure the safety and efficacy of our products.

Key Responsibilities
  • Lead regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while developing strategies to assist product development, registration, and commercialisation.
  • Manage the preparation, compilation, and timely submission of accurate regulatory documentation for new product registrations, variations, renewals, and responses to queries.
  • Serve as the primary liaison with regulatory authorities, maintaining positive relationships while monitoring and conveying developments in the regulatory landscape.
  • Collaborate with cross-functional teams and stakeholders to provide regulatory guidance throughout the product lifecycle, represent regulatory affairs in decision-making processes, and assist with commercialisation.
  • Maintain accurate regulatory records for assigned products in Regulatory Information Management (RIM) platforms, participate in audits to ensure compliance with regulatory standards, and contribute to updating and implementation of Standard Operating Procedures (SOPs) as needed.
Qualifications
  • Bachelor's degree in a scientific discipline or a related field.
  • A minimum of 5 years of experience in regulatory affairs within the pharmaceutical or healthcare industry, with significant expertise in Australian regulatory requirements.
  • Demonstrated proficiency in leading regulatory affairs strategies, preparation and submission of regulatory documentation, regulatory affairs intelligence and the development and approval of product labelling.
  • Strong competency in stakeholder management, comprehensive business and industry knowledge, adaptability in dynamic environments, effective execution, and impactful communication.
  • Must either be an Australian Citizen or Permanent Resident.
What We Offer

We offer a competitive salary range of $120,000 - $150,000 per annum, depending on experience, plus benefits including professional development opportunities and a collaborative work environment.

  • Regulatory Affairs Specialist

    4 weeks ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    Are you passionate about regulatory affairs and eager to play a key role in ensuring the availability of life-changing medicines? We invite you to consider a career as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania.About the DepartmentYou will be part of the Clinical, Medical, Regulatory (CMR) Oceania team, reporting directly to the Senior...

  • Regulatory Affairs Specialist

    5 days ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Novo Nordisk Oceania in Australia and New Zealand. This role will be responsible for leading regulatory affairs activities for assigned products, ensuring compliance with Australian regulatory requirements while developing strategies to assist product development, registration,...

  • Regulatory Affairs Expert

    1 month ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    Are you passionate about regulatory affairs? Do you want to play a key role in ensuring the availability of life-changing medicines? If so, we invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania. Read more and apply today for a life-changing careerAbout the departmentYou will be part of the Clinical, Medical,...

  • Regulatory Affairs Professional

    1 week ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    We are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Novo Nordisk A/S. This role offers an exciting opportunity for individuals passionate about regulatory affairs to play a key role in ensuring the availability of life-changing medicines.As a Senior Regulatory Affairs Associate, you will lead regulatory affairs activities...

  • Regulatory Affairs Professional

    3 weeks ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    About the RoleNovo Nordisk A/S is seeking a highly skilled Senior Regulatory Affairs Associate to join our Clinical, Medical, Regulatory (CMR) Oceania team. As a key member of the team, you will be responsible for leading regulatory affairs activities for assigned products in Australia and New Zealand.Key Responsibilities• Lead regulatory affairs...

  • Regulatory Affairs Expert

    3 weeks ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    About the RoleNovo Nordisk A/S is seeking a Regulatory Affairs Expert to lead regulatory affairs activities for assigned products in Australia and New Zealand.Key ResponsibilitiesLead regulatory affairs activities for assigned products, ensuring compliance with regulatory requirements.Manage the preparation, compilation, and timely submission of accurate...

  • Regulatory Affairs Specialist

    3 weeks 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 months ago

    Sydney, Australia Medella Life Full time

    Location- Sydney- Contact name: - Ethan Keating- Job ref: - 827- Published: - about 2 hours ago**Job Title: Regulatory Affairs Specialist (12-month Contract)** **Location: Hybrid - Sydney, Australia** **Key Responsibilities**: - **Regulatory Compliance**: - Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector,...

  • Regulatory Affairs Specialist

    3 weeks 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

    1 month 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 for New Products and Product Amendments

    1 week ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    We are seeking a highly skilled Regulatory Affairs Specialist to join our Clinical, Medical, Regulatory (CMR) team at Novo Nordisk A/S in Oceania.The successful candidate will have the opportunity to play a key role in leading regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while developing strategies to...

  • Regulatory Affairs Specialist

    3 weeks 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

    4 weeks 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 Expert for Product Development

    2 weeks ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    Are you passionate about regulatory affairs? Do you want to play a key role in ensuring the availability of life-changing medicines?We invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania. This is an exciting opportunity to lead regulatory affairs activities for assigned products in Australia and New Zealand, ensuring...

  • Regulatory Affairs Specialist

    3 weeks 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 Expert for Product Development

    4 hours ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    Company Overview">Novo Nordisk A/S is a global healthcare company with a mission to drive change to defeat diabetes and other serious chronic diseases. Our company culture values collaboration, innovation, and excellence.">About the Role">We are seeking a highly skilled Regulatory Affairs Associate to join our Clinical, Medical, Regulatory (CMR) Oceania team...

  • Senior Regulatory Affairs Associate

    2 months ago

    North Sydney, Australia Novo Nordisk AS Full time

    Are you passionate about regulatory affairs? Do you want to play a key role in ensuring the availability of life-changing medicines? If so, we invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania. Read more and apply today for a life-changing career! About the department You will be part of the Clinical, Medical,...

  • Senior Regulatory Affairs Associate

    2 months ago

    North Sydney, Australia Novo Nordisk Full time

    The position As a Senior Regulatory Affairs Associate, you will: Lead regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while developing strategies to assist product development, registration, and commercialisation. Manage the preparation, compilation, and timely submission of accurate regulatory...

  • Regulatory Affairs Specialist

    4 weeks ago

    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...

  • Regulatory Affairs Expert: Drive Compliance and Growth

    7 days ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    At Novo Nordisk A/S, we're seeking a seasoned Regulatory Affairs Associate to lead our team in ensuring the availability of life-changing medicines. This role offers an exciting opportunity to contribute to the development and commercialization of innovative products while working collaboratively with cross-functional teams.About the RoleAs a Senior...