Strategic Regulatory Expert

6 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000
Job Description

This 12-month contract role offers an opportunity to extend. As a member of the Janssen Regulatory Affairs team, you will report directly to the Senior Manager, Regulatory Affairs.

You will drive business growth by providing regulatory leadership for a portfolio of products. Our Regulatory Affairs team is dedicated to achieving the best outcomes for patients and customers.

Key Responsibilities
  • Develop and execute regulatory strategies to manage local regulatory submissions in Australia and New Zealand.
  • Collaborate with global, regional, and local colleagues to ensure high-quality and timely submissions, with optimal labelling.
  • Participate in cross-functional project teams to lead regulatory discussions, including the development and execution of pipeline strategies to optimize and accelerate launch excellence.
  • Lead ad-hoc departmental projects and initiatives, including TGA/Medsafe consultations and projects initiated by the global/regional Regulatory Affairs.
  • Provide regulatory guidance and expertise to other functions within Janssen to deliver results.
  • Maintain a strong understanding of regulatory environments and guidelines.
Requirements
  • A Bachelor's Degree in Pharmacy or Science or a related field.
  • Previous experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand, including Category 1 and New Medicine Applications.
  • Demonstrated technical expertise working with the TGA and Medsafe.
  • A natural growth mindset – you thrive on challenge and see failure as a springboard for growth and development.
  • Positive can-do attitude and self-motivation with a sense of urgency.
  • Good verbal and written communication skills.
  • Ability to lead from the front, connect with key stakeholders, shape outcomes, and deliver results.
  • Solid stakeholder management and negotiation skills, with a focus on achieving business deliverables.
  • Strong ethical values.
About Us

Janssen prioritizes product innovation, customer focus, and organizational excellence. From research to real-life solutions, we have a long history of developing and marketing treatments that make a meaningful difference.

We believe in combining our expertise with that of others, seeking out the most creative minds in every field. Together, we can find innovative solutions.

Johnson & Johnson - Australia and New Zealand has been recognized as a Great Place to Work in ANZ.

Please note: this position is a contract cover role for 12 months with potential extension.

  • Regulatory Expert

    7 days ago

    Sydney, New South Wales, Australia beBeeregulatory Full time $120,000 - $150,000

    Job Title: Regulatory ExpertWe are seeking a skilled Regulatory Expert to join our team. In this role, you will be responsible for monitoring regulatory developments and advising on their impact to our organization.Your key responsibilities will include:Monitoring regulatory updates and advising on their implicationsRepresenting the team in various...

  • Regulatory Affairs Expert

    3 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000

    Regulatory Affairs LeadAbout the Position:The Regulatory Affairs Lead plays a critical role in driving key regulatory activities, ensuring compliance with relevant regulations and legislation. This individual will bridge strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and...

  • Regulatory Expert

    5 days ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $120,000 - $160,000

    Job DescriptionWe are seeking an experienced professional to join our team as a Senior Compliance Officer.Act as a strategic advisor to senior leadership and the business, providing guidance aligned with regulatory expectations and our risk appetite.Support the execution of our APAC Compliance strategy locally by delivering advisory services, conducting risk...

  • Regulatory Compliance Expert

    2 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000

    Job Title: Regulatory Compliance ExpertAbout the RoleWe are seeking a skilled Regulatory Compliance Expert to provide strategic direction and guidance on healthcare industry regulatory requirements. This individual will work closely with global regulatory bodies, staying up-to-date with best practices and market trends.Main ResponsibilitiesDevelop and...

  • Regulatory Compliance Legal Expert

    3 days ago

    Sydney, New South Wales, Australia beBeeExpert Full time $210,000 - $220,000

    Regulatory Compliance Legal ExpertBeacon Legal is seeking a seasoned Regulatory Compliance Legal Expert to lead the legal stream for regulatory compliance. In this pivotal role, you will partner with senior stakeholders and the General Counsel, providing expert advice on complex regulatory matters and strategic initiatives.The ideal candidate will have 7-10...

  • Regulatory Affairs Expert

    3 days ago

    Sydney, New South Wales, Australia beBeeregulatory Full time $115,000 - $125,000

    Regulatory Affairs Expert | Rare Disease SpecialistThe role of Regulatory Affairs Expert is pivotal in the development, approval, and lifecycle management of innovative medicines. This global position offers a unique opportunity to take full ownership of regulatory affairs across ANZ.Develop and execute strategic regulatory submission plans to support new...

  • Expert Regulatory Advisor

    3 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000

    Regulatory ExpertWe are the payments platform of choice for top companies worldwide, delivering seamless payments across various channels.The role involves monitoring legislative and policy developments to advise on their impact. The successful candidate will represent the team on workstreams and drive regulatory strategy.The ideal candidate is a qualified...

  • Regulatory Expert Lead

    12 hours ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $180,000 - $200,000

    Job Opportunity">The Head of Compliance Advisory will provide expert advice on regulatory obligations and emerging risks, overseeing compliance input into projects, regulatory change programs, and product development.">About the Role">">Delivering strategic compliance guidance to drive business growth">Overseeing compliance input across various initiatives...

  • Regulatory Affairs Expert

    23 hours ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairsLead Full time $200,000 - $250,000

    Regulatory Affairs Lead Job DescriptionThe Regulatory Affairs Lead plays a pivotal role in ensuring compliance with regulatory requirements and driving key activities for the organization.Job Responsibilities:Strategic Guidance: Provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market...

  • Strategic Regulatory Solutions Expert

    3 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $163,000 - $193,000

    Key Regulatory Specialist RoleThe primary objective of this position is to provide strategic support and guidance in the regulatory environment, encompassing all stages of product life cycles. Key deliverables include ensuring compliance and delivering optimal regulatory strategies for portfolio planning, active regulatory intelligence, and excellence in...