Senior Regulatory Affairs Associate

Standort: Australia - Victoria - Abbotsford Datum: Jul 4 2022 Senior Regulatory Affairs Associate, New Product Introduction Our mission at GSK is to improve the quality of lives by enabling people to do more, feel better and live longer. We recognise this starts with our own highly talented team and are committed to supporting, rewarding & developing them with a challenging and inspiring workplace. As part of our highly engaged and high achieving Regulatory Affairs team the Senior Regulatory Affairs Associate, New Product Information (NPI) will be primarily responsible for ensuring submission of high quality, ‘Right First Time’ new product introduction (NPI) regulatory applications in accordance with corporate objectives. The role will see you engaging with a broad range of internal and external stakeholders and will include developing and implementing the agreed regulatory strategy. This role reports into the NPI Regulatory Affairs Manager. Your responsibilities will be broad and will also include: Manage and progress preparation of NPI applications, such as New Chemical Entities (NCEs), New Biological Entities (NBEs) and extension of indications, to meet GSK business objectives and timelines with competitive outcomes. Proactively manage with Local Brand teams and Global groups, and where appropriate, create responses to all regulatory questions received from the Regulatory Authorities of Australia (TGA) and New Zealand (Medsafe) within an agreed priority and timeframe. Effectively manage all labeling text (product information, consumer medicines information leaflets, user patient inserts etc.) for designated pharmaceutical and biological medicines, ensuring that they are in line with the local regulatory approval(s) and labeling regulations and the agreed Global Labeling standards, whilst maintaining maximum competitiveness. Ensuring compliance with all systems and processes. Maintain an awareness of relevant regulatory, industry, legislative, political and competitor activities. Act as a mentor to junior team members. To be successful in this role you will have: A science-based degree or post graduate qualification in a relevant discipline, such as pharmacy, pharmacology, chemistry, or immunology. Experience and subject matter expertise in regulatory affairs within the pharmaceutical industry or government, preferably including experience in major applications (NCEs, NBEs, extension of indications, etc). Exceptional written and verbal communication skills with the ability to foster positive and proactive relationships with a broad range of stakeholders including the TGA/Medsafe, Industry Associations and a broad range of internal stakeholders. Strong analytical skills, excellent attention to detail and a commitment to compliance processes. Excellent presentation skills. GSK is a place where outstanding people do amazing things. We have clear values and expectations and we put them at the heart of everything we do. At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. About GSK: At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster; accountable for impact – with clear ownership of goals and support to succeed; and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together *LI-GSK Unser Ziel ist es, eines der innovativsten, leistungsfähigsten und vertrauenswürdigsten Gesundheitsunternehmen der Welt zu werden. Wir sind davon überzeugt, dass jeder von uns einen einzigartigen Beitrag zu GSK leistet. 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