Business Process Manager- Regulatory Affairs

2 days ago

Sydney, New South Wales, Australia Resmed Full time

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

  • 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 AffairsDescription: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...

  • Regulatory Affairs Manager

    4 weeks ago

    Sydney, New South Wales, Australia Heng & Hurst Full time

    Regulatory Affairs Manager | Rare Disease | SYDJoin to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & Hurst Regulatory Affairs Manager | Rare Disease | SYD1 day ago Be among the first 25 applicants Join to apply for the Regulatory Affairs Manager | Rare Disease | SYD role at Heng & Hurst Get AI-powered advice on this job and...

  • Regulatory Affairs Manager

    3 days ago

    Sydney, New South Wales, Australia Blackmores Group Full time

    As a purpose-led, performance-driven organisation, Blackmores Group strives to create remarkable employee experiences through supporting a diverse and inclusive culture, creating leadership that inspires high performance, and providing everyone with opportunities to achieve their professional, personal and wellbeing goals supported by our flexible work...

  • Regulatory Affairs Expert

    1 week 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...

  • Regulatory Affairs Expert

    7 days ago

    Sydney, New South Wales, Australia beBeeRegulatoryAffairsLead Full time $200,000 - $250,000

    Regulatory Affairs Lead Job DescriptionThe Regulatory Affairs Lead plays a pivotal role in ensuring compliance with regulatory requirements and driving key activities for the organization.Job Responsibilities:Strategic Guidance: Provide expert advice on product registration pathways, regulatory strategies, and business acquisitions to support speed to market...

  • Regulatory Affairs Lead

    3 days 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...

  • Manager, Regulatory Affairs, APAC

    1 day ago

    Sydney, New South Wales, Australia Johnson & Johnson Innovative Medicine Full time

    OverviewJohnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate...

  • Manager, Regulatory Affairs, APAC

    1 day ago

    Sydney, New South Wales, Australia Johnson & Johnson Innovative Medicine Full time

    OverviewJohnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate...

  • Manager, Regulatory Affairs, Apac

    3 days ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    Job title Manager, Regulatory Affairs, APAC Function Regulatory Affairs Group Sub function Regulatory Affairs Category Manager, Regulatory Affairs (P7) Location Singapore / Mongkok / North Ryde / Petaling Jaya / Seoul / Taipei City / Singapore / Hong Kong / Australia / Malaysia / Korea, Republic of / Taiwan Date posted Sep 02 2025 Requisition number R-030104...

  • Regulatory Affairs Expert

    1 week ago

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

    Regulatory Affairs LeadAbout 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...