Business Process Manager- Regulatory Affairs (2 Years, Fixed Term)

Posted:
6/18/2025, 1:55:11 PM

Location(s):
New South Wales, Australia ⋅ Sydney, New South Wales, Australia

Experience Level(s):
Mid Level ⋅ Senior

Field(s):
Business & Strategy

We are looking for a Business Process Manager – Regulatory Affairs to lead a dedicated team focused on optimizing regulatory workflows and ensuring global compliance across our operations. This is a critical leadership role where you'll work cross-functionally to drive business efficiency, support transformation, and elevate the performance of the Regulatory Affairs (RA) function.

What You'll Be Doing

Process Excellence & Optimization

  • Lead process mapping and analysis using BPMN 2.0 standards to document, standardize, and improve RA workflows.

  • Identify bottlenecks and deliver continuous improvement initiatives using proven methodologies (Lean, Kaizen, Six Sigma).

  • Develop, maintain, and scale Standard Operating Procedures (SOPs) and supporting documentation.

  • Build and deploy training materials to ensure process adoption and knowledge transfer.

Change Management

  • Design and implement change management strategies that 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 the 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.

What You'll Bring

  • 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.

Why Join Us?

This is more than a process role — it's an opportunity to shape how regulatory excellence is delivered globally. You’ll influence strategy, lead innovation, and empower teams to work smarter and more effectively. If you’re a collaborative leader with a knack for making complex processes work seamlessly, we’d love to hear from you.

#LI-APAC

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!