Regulatory Affairs Expert

1 day ago

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

About 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 point of escalation for complex regulatory matters.

Main Responsibilities:

  • Strategic Regulatory Guidance: Provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market and alignment with commercial goals.
  • Risk Management and Compliance: Identify and mitigate regulatory risks, ensuring compliance with legislation, standards, and corporate procedures while supporting post-market activities and change management.
  • Process Improvement and Implementation: Drive the implementation of new regulatory processes and contribute to continuous improvement initiatives that enhance compliance and operational efficiency.
  • Stakeholder Engagement and Issue Resolution: Act as a key escalation point for complex regulatory issues, offering strategic solutions and collaborating across teams to resolve challenges effectively.
  • Leadership and Team Development: Mentor and coach team members, fostering growth and building technical competency to strengthen regulatory expertise across the team.

Required Skills and Qualifications:

  • A minimum of 8 years' experience within a Regulatory Affairs, Quality, or similar field and demonstrable success in analysis and interpretation of regulatory documentation and technical writing.
  • Tertiary qualifications in a technical discipline (e.g., Science, Engineering, or related).
  • Strong communication, negotiation, and influencing skills – the ability to quickly build meaningful relationships with internal teams, external stakeholders, and government departments.
  • A self-driven, strategic thinker who can balance attention to detail and quality, with the ability to thrive in a fast-paced environment and high-performance and growth organisation.

About You:

You are an experienced regulatory professional with significant experience in a similar Regulatory Affairs role. You possess strong leadership, strategic thinking, and technical expertise, with a proactive approach and a proven ability to coach teams and influence stakeholders.

We Are Looking for Someone Who:

  • Has a strong understanding of regulatory requirements and legislation.
  • Can develop and implement effective regulatory strategies.
  • Is able to lead and manage cross-functional teams.
  • Has excellent communication and interpersonal skills.
  • Is a strategic thinker with a proactive approach.

  • Regulatory Affairs Expert

    1 day 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 Affairs Professional

    7 hours ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $135,000 - $155,000

    Job Title: Regulatory Affairs ExpertJob Description:We are seeking a highly skilled Regulatory Affairs professional to join our team on a short-term, part-time basis during a critical period.As a Regulatory Affairs expert in the post-market regulatory field, you will work across various activities to ensure compliance for our marketed medical devices.The...

  • Expert Regulatory Affairs Professional

    7 hours ago

    Sydney, New South Wales, Australia beBeeDiversity Full time $80,000 - $120,000

    Regulatory Affairs ExpertWe are seeking a highly skilled Regulatory Affairs professional to join our team. As an Advisor, you will lead engagement across APRA to ensure our external regulatory relationships are supported by relevant subject matter expertise.The successful candidate will work on a broad range of diverse issues that are important to...

  • Regulatory Affairs Expert

    7 hours ago

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

    Senior Specialist Regulatory AffairsThis is a highly skilled and experienced Senior Specialist Regulatory Affairs role in Sydney, Australia. The successful candidate will have significant expertise in regulatory affairs within the medical devices industry, with a proven track record of leading global regulatory submissions.Key Responsibilities:Author and...

  • Regulatory Affairs Specialist

    16 minutes ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $90,000 - $110,000

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to deliver regulatory submissions and maintain compliance.Deliver regulatory submissions on time;Ensure accurate company databases and systems by drafting, updating, reviewing and verifying entries;Maintain compliance with regulations and provide expert advice as...

  • Regulatory Affairs Expert

    1 day ago

    Sydney, New South Wales, Australia beBeeTechnical Full time $150,000 - $200,000

    About UsOur team leads regulatory strategy and delivery for products, including masks, CPAP devices, ventilators, and accessories. We support both new product introduction and product lifecycle engineering across high-volume, global portfolios.As an individual contributor in this team, you will partner with cross-functional teams and global stakeholders to...

  • Regulatory Affairs Specialist

    6 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000

    Regulatory Affairs ExpertWe are seeking a skilled Regulatory Affairs Manager to build and lead our regulatory affairs team.The ideal candidate will have experience in software-as-medical-device and in-vitro diagnostic device regulations, as well as excellent interpersonal skills.Key responsibilities include preparing international regulatory submissions,...

  • Expert Regulatory Affairs Professional

    3 days ago

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

    Regulatory Affairs Role OverviewThe Regulatory Affairs Specialist is responsible for ensuring compliance with healthcare industry regulatory requirements.Key Responsibilities:Develops and implements strategies to support business objectives by staying up-to-date on global regulatory bodies and best practices.Collaborates with cross-functional teams to ensure...

  • Regulatory Affairs Expert

    24 hours ago

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

    Job Summary:We are seeking a skilled Regulatory Affairs Associate to join our team.Main ResponsibilitiesRegulatory SubmissionsDeliver timely and accurate regulatory submissions to support product registration and maintenance activities.Data ManagementMaintain up-to-date and accurate company databases and systems by drafting, reviewing, and verifying...

  • Senior Regulatory Affairs Expert

    22 hours ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $138,000 - $188,500

    Regulatory Affairs SpecialistJob OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to lead our global regulatory strategy and submission execution for physical products manufactured by our company. As a key member of the team, you will play a critical role in shaping the future of our business.Main Responsibilities:Develop and execute...