Regulatory Affairs Specialist

2 days ago

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

The Regulatory Affairs Specialist is responsible for overseeing and driving key regulatory activities, ensuring compliance with relevant regulations and legislation.

This role bridges 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. Additionally, the Regulatory Affairs Specialist will coach and mentor team members, providing guidance to support their professional development.

You will bring a depth of knowledge and experience working within highly regulated industries, interacting with regulatory authorities and navigating complex regulatory environments. You also have strong leadership, strategic thinking, and technical expertise, with a proactive approach and a proven ability to coach teams and influence stakeholders.

  • 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; and
  • Leadership and team development: Mentor and coach team members, fostering growth and building technical competency to strengthen regulatory expertise across the team

Key qualifications include:

  • 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; and
  • 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 organisation;

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