Regulatory Affairs Project Manager

Great Place to Work Certified - 2022
From Research to Real-life Solutions
Exposure to a diverse range of Therapeutic areas
Benefits include: Onsite parking, Gym, Fitness Reimbursement, Volunteer Days, and much more
Location: NSW, North Ryde (open to other states) + flexible work practices

ABOUT THE COMPANY

At 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 OPPORTUNITY

Janssen 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.

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
Qualifications

IT'S ALL ABOUT YOU

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

COMPANY CULTURE

You 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– 2022

Great 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 for—all backgrounds, beliefs and the entire range of human experience—coming 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.

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