Job Title

Great Place to Work Certified - 2022From Research to Real-life SolutionsExposure to a diverse range of Therapeutic areasBenefits include: Onsite parking, Gym, Fitness Reimbursement, Volunteer Days, and much moreLocation: NSW, North Ryde (open to other states) + flexible work practicesABOUT THE COMPANYAt Janssen, everything we do is engineered with the patient in mind. It drives us to search for new ideas and innovative healthcare solutions. We embrace challenges and develop treatments that will change the lives of our patients.We believe in connecting our own expertise and capabilities with those of others, seeking the most creative minds in every field. Together we can find transformational solutions.At Janssen, we collaborate with the world for the health of everyone in it.THE OPPORTUNITYJanssen is looking for a Regulatory Affairs Project Manager or a Senior Regulatory Affairs Associate who is ready for a step-up to join the Janssen Regulatory Affairs team reporting into the Senior Manager, Regulatory Affairs. You will support our business growth through providing regulatory leadership of a portfolio of products.Our Regulatory Affairs team are very skilled and passionate individuals committed to getting the best outcomes for the patients and the customers that we serve. Working in the pharmaceutical industry, you will be exposed to a broad range of products that will have life changing effects on patients'' quality of life.If you are excited by and have experience in Regulatory Affairs, specifically with prescription medicines, and would like to be exposed to a broad range of therapy areas, this role is for you.RESPONSIBILITIESLead a product portfolio to plan regulatory strategies and manage local regulatory submissions for Australia and New ZealandLiaise 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 labellingBe 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 excellenceLead ad-hoc departmental projects and initiatives including TGA/Medsafe consultations and projects initiated by the global/regional Regulatory AffairsProvide regulatory guidance and expertise to other functions within Janssen to deliver outcomesEnsure all relevant work is undertaken in compliance with local regulation requirements and local and global corporate standardsMaintain a good understanding of the regulatory environment and guidelinesQualificationsIT''S ALL ABOUT YOUA Bachelor''s Degree in Pharmacy or Science or related field, and any additional qualifications such as a PhD or Masters would be highly regardedExtensive previous experience in Regulatory Affairs, preferably in prescription medicines within Australia and New Zealand including Category 1 and New Medicine ApplicationsDemonstrated strong technical expertise working with the TGA and MedsafeA natural growth mindset you thrive on challenge and see failure as a springboard for growth and developing your abilitiesPositive can-do attitude and are self-motivated with a sense of urgencyExcellent verbal and written communication skillsStrong project management skills including critical thinking and problem solving, negotiation, time management and risk managementDemonstrated ability to lead from the front, connect with key internal and external stakeholders, ability to shape outcomes and deliver resultsExtremely strong ethical valuesCOMPANY CULTUREYou will be rewarded through a competitive remuneration package along with continuous training, support and award-winning leadership development programs.Being part of Johnson & Johnson can change everything, including YOU:Janssen is driven by dedication to product innovation, customer focus, and organisational excellence. From research to real-life solutions, Janssen has a long track record in developing and marketing treatments that make a real difference.Great Place to Work Certified 2022Great Place to Work Certification recognises employers who create outstanding employee experience. The certification process is recognised worldwide as the global benchmark for identifying outstanding workplaces.Johnson & Johnson - Australia and New Zealand was certified as a Great Place to Work in ANZ in its first year of participation.If you are interested, please apply online using the link below. You will receive an automated email confirming receipt of your application. Every application is reviewed by the Talent Acquisition team and candidates will receive notification of the outcome of their application in a timely manner.Closing date: COB 11:59pm Wednesday 22nd February 2023.Johnson & Johnson is 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. We are committed to working in partnership with and support Aboriginal and Torres Strait Islander peoples and organisations by recognising and respecting the diversity of cultures, identity, heritage, languages, lores, and social and spiritual systems practiced. We draw pride and strength from you, your colleagues and the world we care forall backgrounds, beliefs and the entire range of human experiencecoming together to bring health to billions.As a leading global healthcare provider, Johnson & Johnson has implemented a COVID-19 Vaccine Policy in Australia which requires all staff to be fully vaccinated for COVID-19 in order to commence work, unless they have a valid exemption.Agencies please note: This recruitment assignment is being managed directly by Johnson & Johnson''s Talent Acquisition team. We will reach out to our preferred agency partners in the rare instance we require additional talent options. Your respect for this process is appreciated.