Regulatory Affairs Portfolio Lead

1 week ago

Sydney, New South Wales, Australia beBeeRegulatory Full time $104,000 - $130,878
Job Overview

We are seeking a Regulatory Affairs Project Manager to lead our team in Australia and New Zealand.

The Opportunity

This is an exciting opportunity for a skilled professional to join us and contribute to the growth of our business.

As a Regulatory Affairs Project Manager, you will be responsible for leading a product portfolio, planning regulatory strategies, and managing local regulatory submissions.

You will collaborate with global, regional, and local colleagues to ensure high-quality and timely outcomes.

Main Responsibilities:

  • Lead a product portfolio to plan regulatory strategies and manage local regulatory submissions for Australia and New Zealand.
  • Liaise proactively and work collaboratively with global, regional, and local colleagues in the management of applications throughout the submission and evaluation processes to ensure a high quality and timely outcome, with the optimum labelling.
  • Be an active member of cross-functional project teams to lead regulatory discussions, including the development and execution of strategies for pipeline products to optimise 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 our organisation to deliver outcomes.
  • Ensure all relevant work is undertaken in compliance with local regulation requirements and local and global corporate standards.
  • Maintain a good understanding of the regulatory environment and guidelines.
Key Requirements

To succeed in this role, you will need:

  • Strong regulatory knowledge and experience in managing local regulatory submissions.
  • Excellent communication and collaboration skills.
  • Able to lead and manage cross-functional project teams.
  • Good problem-solving and analytical skills.
  • Able to work under pressure and meet deadlines.

Benefits:

This role offers a challenging and rewarding career opportunity with a dynamic and growing organisation. We offer a competitive salary and benefits package, as well as opportunities for professional development and growth.

About Us:

We are a innovative healthcare organisation dedicated to improving patient lives. We are passionate about delivering high-quality solutions that make a real difference in people's lives.

  • Regulatory Affairs Portfolio Leader

    7 days ago

    Sydney, New South Wales, Australia beBeePortfolio Full time $104,000 - $130,878

    Portfolio Manager OpportunityWe are seeking an experienced Regulatory Affairs Portfolio Manager to provide strategic leadership for a portfolio of products. This role will support business growth and patient outcomes by developing and executing regulatory strategies.About the RoleThe successful candidate will be responsible for leading product portfolios,...

  • Regulatory Affairs Lead

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $130,000

    We are seeking a seasoned Regulatory Affairs Manager to lead and manage regulatory affairs for listed medicines across Australia and New Zealand.This is an exciting opportunity to oversee day-to-day operations, strategic planning, and cross-functional collaboration, while fostering a high-performance team culture.Develop and implement regulatory strategies...

  • Regulatory Affairs Expert

    7 days ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $160,000 - $200,000

    Key Regulatory Affairs PositionThe primary function of our Regulatory Affairs team is to provide support and guidance in navigating the regulatory environment throughout the product life cycle. This role involves ensuring compliance and delivering optimal regulatory strategies for portfolio planning, active regulatory intelligence, and excellence in...

  • Regulatory Affairs Associate

    1 week ago

    Sydney, New South Wales, Australia Pfizer Full time

    Why Patients Need YouThis is a great opportunity to become part of a dedicated and successful Regulatory Department and to help us make a meaningful difference to the lives of patients in Australia and New Zealand. Our Team is talented, collaborative, diverse and made up of experienced regulatory professionals who always strive for the best outcomes for...

  • Strategic Regulatory Affairs Leader

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $140,000 - $170,000

    Regulatory Affairs Manager PositionThis is an exciting opportunity for a Regulatory Affairs Manager to lead regulatory strategies and manage submissions.The ideal candidate will have expertise in regulatory affairs, specifically with prescription medicines, and be able to work collaboratively with colleagues to ensure high-quality and timely outcomes.About...

  • Strategic Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $180,000 - $220,000

    Regulatory Affairs Leadership RoleThis is a 12-month contract position providing regulatory leadership of a portfolio of products and supporting business growth.Key Responsibilities:Lead a product portfolio to develop and implement regulatory strategies, manage local regulatory submissions for Australia and New Zealand, and drive business growth.Collaborate...

  • Regulatory Affairs Specialist

    2 weeks ago

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

    About the OpportunityRegulatory Affairs ProfessionalLead a portfolio of products to plan regulatory strategies and manage submissions for Australia and New Zealand.Liaise with global, regional and local colleagues to ensure timely and high-quality outcomes.Key ResponsibilitiesThe successful candidate will be responsible for leading ad-hoc departmental...

  • Senior Regulatory Affairs Professional

    7 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $104,000 - $130,878

    Regulatory Affairs Specialist PositionWe are seeking a highly skilled Regulatory Affairs Specialist to lead our portfolio of products in Australia and New Zealand.About the RoleThe successful candidate will provide regulatory leadership, plan strategies, and manage local submissions for the region.Key Responsibilities:Lead product portfolio planning and...

  • Senior Specialist Regulatory Affairs

    2 weeks ago

    Sydney, New South Wales, Australia Resmed Full time

    OverviewThe Sydney Regulatory Affairs team leads regulatory strategy and submission execution for physical products where ResMed Pty Ltd is the legal manufacturer, including masks, CPAP devices, ventilators, and accessories.The team supports both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) across high-volume, global portfolios.The...

  • Regulatory Affairs Expert

    2 weeks ago

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

    Regulatory Affairs Associate Job OpportunityWe are seeking a highly skilled and motivated Regulatory Affairs Associate to join our team. As a key member of our regulatory affairs group, you will play a crucial role in ensuring continuity of supply via life cycle maintenance activities for our existing portfolio and supporting the registration of new...