Regulatory Affairs Process Transformation Expert

2 days ago

Sydney, New South Wales, Australia beBeeProcess Full time $120,000 - $180,000
Job Title:

Process Optimization Leader - Regulatory Affairs

Description:

We are seeking a seasoned professional to lead process optimization initiatives in Regulatory Affairs, driving global compliance and operational excellence.

This is an opportunity to shape how regulatory excellence is delivered globally. You will influence strategy, lead innovation, and empower teams to work smarter and more effectively.

Key Responsibilities:
  • Lead the development and implementation of process maps using BPMN 2.0 standards to document and standardize RA workflows.
  • Analyze and identify bottlenecks in RA processes, developing and implementing continuous improvement initiatives using Lean and Six Sigma methodologies.
  • Design, develop, and maintain Standard Operating Procedures (SOPs) and supporting documentation.
  • Develop and deploy training materials to ensure process adoption and knowledge transfer.
Change Management:
  • Design and implement change management strategies to support the successful rollout of updated or new regulatory processes.
  • Monitor adoption, gather feedback, and adapt plans as needed to ensure sustained success.
Cross-Functional Collaboration:
  • Act as a bridge between RA and key partners in Quality, Supply Chain, and Product Development to align on requirements, address pain points, and drive end-to-end process efficiency.
  • Ensure strong communication and transparency with all stakeholders to foster trust and alignment.
Team Leadership:
  • Manage and mentor a high-performing team focused on regulatory process improvement.
  • Champion a culture of business excellence through coaching, upskilling, and goal-setting.
  • Serve as a strategic thought partner to RA leadership on business transformation initiatives.
Requirements:
  • Education: Bachelor's degree in Life Sciences, Engineering, Regulatory Affairs, or a related discipline (Advanced degree preferred).
  • Minimum 5 years of experience in Regulatory Affairs, Quality, Operations, or Process Excellence in a regulated industry.
  • Proficiency in business process modeling (e.g. BPMN 2.0).
  • Hands-on experience with continuous improvement tools such as Lean, Six Sigma, or Kaizen.
  • Strong communication, stakeholder management, and influencing skills.
  • Ability to work across complex regulatory environments and cross-functional teams.
Preferred Qualifications:
  • Proven success in people management, coaching, and developing high-potential talent.
  • Exposure to Regulatory Affairs in the medical device or pharmaceutical industry.
  • Professional certifications such as Lean Six Sigma, CBAP, or BPM methodologies.

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