Regulatory Affairs Specialist
1 month ago
Johnson & 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 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.
About the Company:
Johnson & Johnson is a leading global healthcare provider, driven by dedication to product innovation, customer focus, and organisational excellence. 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.
Skills and Qualifications:
- 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.
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