Regulatory Affairs Project Manager

2 months ago

Sydney, New South Wales, Australia Johnson & Johnson Full time
About the Role

We are seeking a highly skilled Regulatory Affairs Project Manager to join our team at Johnson & Johnson. As a key member of our Regulatory Affairs team, you will play a critical role in ensuring the successful launch of our products in 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 and work collaboratively with global, regional, and local colleagues in the management of applications throughout the submission and evaluation processes to ensure a high quality and timely outcome, with the optimum labelling
  • Be an active member of the cross-functional project teams to lead regulatory discussions, including the development and execution of strategies for pipeline products to optimise and accelerate launch excellence
  • 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 outcomes
  • Ensure all relevant work is undertaken in compliance with local regulation requirements and local and global corporate standards
  • Maintain a good understanding of the regulatory environment and guidelines
Requirements
  • A Bachelor's Degree in Pharmacy or Science or related field, and any additional qualifications such as a PhD or Masters would be highly regarded
  • Extensive previous experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand including Category 1 and New Medicine Applications
  • Demonstrated strong technical expertise working with the TGA and Medsafe
  • A natural growth mindset – you thrive on challenge and see failure as a springboard for growth and developing your abilities
  • Positive can-do attitude and are self-motivated 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
  • Demonstrated ability to lead from the front, connect with key internal and external stakeholders, ability to shape outcomes and deliver results
  • Extremely strong ethical values
About Us

At Johnson & Johnson, we are driven by a passion to improve the health and well-being of people around the world. We are committed to innovation, customer focus, and organisational excellence. Our team is passionate about developing and marketing treatments that make a real difference in people's lives.

We are a Great Place to Work Certified company, recognised for our commitment to creating an outstanding employee experience. We believe in diversity, equity, and inclusion, and are committed to working in partnership with and support Aboriginal and Torres Strait Islander peoples and organisations.

We are an equal opportunity employer who supports inclusive, flexible and accessible working arrangements for all. This includes persons with disabilities, culturally, religiously and linguistically diverse people, diverse age groups, diverse sexual orientation, and gender.

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