Regulatory Strategy Coordinator

2 days ago

Sydney, New South Wales, Australia beBeeRegulatoryAffairsManager Full time $120,000 - $150,000
Job Opportunity

About the Position:

We are seeking an experienced Regulatory Affairs Project Manager to lead a product portfolio in planning regulatory strategies and managing submissions for Australia and New Zealand.

Key Responsibilities:

  • Lead a product portfolio to plan regulatory strategies and manage local regulatory submissions for Australia and New Zealand.
  • Liaise proactively with global, regional, and local colleagues to ensure high-quality and timely outcomes.
  • Be an active member of cross-functional project teams to lead regulatory discussions and develop execution strategies for pipeline products.
  • Lead ad-hoc departmental projects and initiatives including TGA/Medsafe consultations and projects initiated by the global/regional Regulatory Affairs.
  • Provide regulatory guidance and expertise to other functions within Janssen to deliver results.
  • Ensure all work is undertaken in compliance with local regulation requirements and corporate standards.
  • Maintain knowledge of the regulatory environment and guidelines.

Required Skills and Qualifications:

  • Bachelor's Degree in Pharmacy or Science or related field, with additional qualifications like a PhD or Masters highly regarded.
  • Extensive experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand.
  • Demonstrated technical expertise working with the TGA and Medsafe.
  • Natural growth mindset – thrive on challenge and see failure as a learning opportunity.
  • Positive attitude and self-motivation with a sense of urgency.
  • Excellent verbal and written communication skills.
  • Strong project management skills including critical thinking and problem solving, negotiation, time management, and risk management.
  • Able to lead from the front, connect with key stakeholders, shape outcomes, and deliver results.
  • Strong ethical values.

Benefits:

Janssen offers a competitive remuneration package along with continuous training, support, and award-winning leadership development programs. We foster a culture of innovation, customer focus, and organisational excellence.

About Us:

We strive to develop and market treatments that make a real difference. Our long track record of research and real-life solutions drives us forward.

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