Regulatory Affairs Project Manager

1 month 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 be responsible for providing regulatory leadership and strategic direction 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 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 creating a workplace that is welcoming and inclusive for all.

Johnson & Johnson is an equal opportunity employer who supports inclusive, flexible and accessible working arrangements for all. 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 are a leading global healthcare provider, and as such, we have 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.

  • Senior Regulatory Advisor

    1 month ago

    Sydney, New South Wales, Australia Regulatory Affairs Full time

    Job Title: Senior Regulatory AdvisorJoin our Regulatory Affairs team as a Senior Regulatory Advisor and play a pivotal role in ensuring compliance at The Star. As a key member of our team, you will be responsible for supporting the business in understanding their regulatory obligations and assisting in progressing business initiatives for approval.About the...

  • Regulatory Affairs Project Manager

    2 months ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe 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 timely and successful submission of regulatory applications for our products in Australia and New Zealand.Key ResponsibilitiesLead a product...

  • Regulatory Affairs Project Manager

    2 months ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe 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 ResponsibilitiesLead a product portfolio to plan regulatory strategies and...

  • Regulatory Affairs Project Manager

    2 weeks ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleAs a Regulatory Affairs Project Manager at Johnson & Johnson, you will play a critical role in supporting our business growth by providing regulatory leadership of a portfolio of products. You will be responsible for planning regulatory strategies and managing local regulatory submissions for Australia and New Zealand.Key Responsibilities* Lead...

  • Regulatory Affairs Project Manager

    2 months ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe 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 ResponsibilitiesLead a product portfolio to plan regulatory strategies and...

  • Regulatory Affairs Project Manager

    2 months ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe 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 ResponsibilitiesLead a portfolio of products to plan regulatory strategies and...

  • Regulatory Affairs Manager

    4 weeks ago

    Sydney, New South Wales, Australia Novartis Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Novartis. As a Regulatory Affairs Manager, you will be responsible for overseeing the planning and coordination of submissions to health authorities in Australia and New Zealand, ensuring compliance with local laws and regulations.Key ResponsibilitiesDevelop and...

  • Regulatory Affairs Project Lead

    6 days ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Project Manager to join our team. As a key member of our Regulatory Affairs team, you will be responsible for leading the development and implementation of regulatory strategies for a portfolio of products.You will work closely with cross-functional teams to ensure that regulatory submissions...

  • Regulatory Affairs Manager

    3 weeks ago

    Sydney, New South Wales, Australia Novartis Full time

    SummaryInternal Role Title: Regulatory Affairs ManagerLocation: Sydney, AustraliaAbout the Role:As a Regulatory Affairs Manager at Novartis, you will be responsible for managing, planning, and coordinating submissions to health authorities in Australia and New Zealand. You will report to the Head of Regulatory Affairs and develop strategies to deliver...

  • Regulatory Affairs Manager

    3 weeks ago

    Sydney, New South Wales, Australia Novartis Full time

    About the RoleAs a Regulatory Affairs Manager at Novartis, you will play a critical role in managing, planning, and coordinating submissions to health authorities in Australia and New Zealand. Reporting to the Head of Regulatory Affairs, you will develop strategies to deliver optimal regulatory outcomes, ensure compliance with all local laws, regulations,...

  • Regulatory Affairs Specialist

    6 days ago

    Sydney, New South Wales, Australia Johnson & Johnson Full time

    Regulatory Affairs Specialist Position OverviewJohnson & Johnson is currently seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs team, you will play a critical role in supporting our business growth by providing regulatory leadership of a portfolio of products.Main Responsibilities:Lead a...

  • Regulatory Affairs Specialist

    3 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    About the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team as a Senior Consultant. As a key member of our Regulatory, Quality & Compliance team, you will be responsible for managing complex regulatory projects for clients in Australia, New Zealand, and the JAPAC region.Key Responsibilities:Develop and implement regulatory...

  • Regulatory Affairs Expert

    1 day ago

    Sydney, New South Wales, Australia Pharmiweb Full time

    Regulatory Affairs Consultant RoleWe are seeking a skilled Regulatory Affairs Consultant to join our team at Pharmiweb. As a key member of our dynamic team, you will provide strategic guidance on regulatory requirements and submissions in Germany and Switzerland.Key Responsibilities:Provide strategic guidance on regulatory requirements and submissions in...

  • Regulatory Affairs Specialist

    2 months ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ResMed Inc. as a Specialist, Regulatory Postmarket Compliance. This role will be responsible for leading regulatory affairs strategy to ensure compliance with postmarket regulations and quality standards.Key ResponsibilitiesDevelop and implement regulatory postmarket...

  • Senior Regulatory Affairs Manager

    2 weeks ago

    Sydney, New South Wales, Australia PharmaLex Full time

    Your RoleWe have an opportunity for an experienced Regulatory Professional to join our team in Australia. As a Seasoned Regulatory Affairs Specialist, you will be responsible for ensuring the compliance of products with regulatory requirements. Your primary objective is to maximize commercial success by advising clients on licensing, marketing, and...

  • Regulatory Affairs Director

    1 month ago

    Sydney, New South Wales, Australia Novartis Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Novartis. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with local laws, regulations, and company policies.Key ResponsibilitiesDevelop and implement broader regulatory strategies within the team, managing...

  • Regulatory Affairs Director

    3 weeks ago

    Sydney, New South Wales, Australia Novartis Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Novartis. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with local laws, regulations, and company policies.Key ResponsibilitiesDevelop and implement broader regulatory strategies within the team, managing...

  • Regulatory Affairs Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    About the RoleWe are seeking a highly skilled Senior Consultant to join our Regulatory, Quality & Compliance team. As a Senior Consultant, you will be responsible for managing complex regulatory projects for clients in Australia, New Zealand, and the JAPAC region.Key ResponsibilitiesDevelop and implement regulatory strategies and pathways for clientsPrepare...

  • Regulatory Affairs Specialist

    2 months ago

    Sydney, New South Wales, Australia Randstad Full time

    Exciting Career Opportunity in Nutrition Regulatory AffairsWe are seeking a skilled professional to manage and develop regulatory strategies for our extensive portfolio of nutritional products across Australia and New Zealand.This role offers the opportunity to work at the forefront of nutritional science, influencing products that impact health and...

  • Regulatory Affairs Specialist

    4 weeks ago

    Sydney, New South Wales, Australia Healthcare Professionals Group Full time

    About the RoleWe are seeking a highly skilled Senior Consultant to join our Regulatory, Quality & Compliance team. As a Senior Consultant, you will be responsible for managing complex regulatory projects for clients in Australia, New Zealand, and the JAPAC region.Key ResponsibilitiesDevelop and implement regulatory strategies and pathways for clientsPrepare...