Senior Regulatory Affairs Associate

4 weeks ago

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

Johnson & Johnson is seeking a highly skilled Senior Regulatory Affairs Associate to join their team. As a key member of the Regulatory Affairs team, you will be responsible for providing regulatory leadership and support for a portfolio of products.

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 pipeline strategies 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 good understanding of regulatory environment and guidelines

Requirements

* A Bachelor's Degree in Pharmacy or Science or related field
* 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
* Good verbal and written communication skills
* Demonstrated ability to lead from the front, connect with key internal and external stakeholders, ability to shape outcomes and deliver results
* Solid stakeholder management and negotiation skills, and achieving business deliverables
* Extremely strong ethical values

About Johnson & Johnson

Johnson & Johnson is a global healthcare leader that is driven by a commitment to innovation, customer focus, and organisational excellence. We are dedicated to developing and marketing treatments that make a real difference in the lives of our patients. As a Great Place to Work Certified company, we offer a competitive remuneration package, continuous training, support and award-winning leadership development programs. If you are passionate about regulatory affairs and want to be part of a dynamic team, please apply online using the link below.

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