Regulatory Affairs Professional
1 week ago
Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world.
As a Senior Manager, Regulatory Affairs at Gilead Sciences in Melbourne, Australia, you will play a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.
The successful candidate will assume a 12-mth contract in the Regulatory Affairs department and report to the Senior Director, Regulatory Affairs. The position will remain open until a suitable candidate is found.
Job Responsibilities:- Prepare regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for Australia and New Zealand in line with ICH requirements and scientific and company policies and procedures.
- Submit marketing authorisation and variations, safety reports, amendments, supplements, clinical trial applications, authorizations, original, and marketing authorization applications for territories other than the US and EU.
- Provide local regulatory expertise for labelling changes and to submission teams on specified projects and topics.
- Contribute to the preparation of country specific labelling.
- Ensure product packaging and associated information is updated and maintained in accordance with the product licenses.
- Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to complex programs/projects.
- Develop own self-development and acquisition of required regulatory skills and knowledge under guidance of immediate manager.
- Initiate or contribute to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments.
In addition, excellent organization skills and ability to work on a number of projects with tight timelines is required. Excellent verbal and written communication skills and interpersonal skills are also necessary.
This role requires a minimum of 8 years of experience in Australian Regulatory Affairs. Extensive experience negotiating and interacting with the Therapeutic Goods Administration is essential. You must be able to perform as a senior member of a team with diverse membership from all functions and levels of the company. A degree in a scientific field is preferred.
-
Regulatory Affairs Executive
4 weeks ago
Melbourne, Victoria, Australia Pharmiweb Full timeJob Title:Regulatory Affairs ExecutiveAbout the Role:Pharmiweb is seeking an experienced Regulatory Affairs Executive to lead our regulatory compliance efforts. The ideal candidate will have a strong background in regulatory affairs and excellent leadership skills.Main Responsibilities:Develop and implement regulatory strategies to ensure compliance with...
-
Regulatory Affairs Manager, Global Compliance
3 weeks ago
Melbourne, Victoria, Australia Gilead Sciences Full timeGilead Sciences is a research-based biopharmaceutical company committed to creating innovative medicines for unmet medical needs. Our team in Melbourne, Australia, is seeking a highly skilled Regulatory Affairs professional to join our cross-functional department.Job DescriptionThis 12-month contract role will report to the Senior Director, Regulatory...
-
Regulatory Affairs Specialist
4 weeks ago
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeJob OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our Global Regulatory Affairs Office (GRAO). This key role will provide subject matter expertise across a multi-year regulatory and risk program, focusing on risk management, remediation of regulatory and audit findings, and administration of regulatory affairs.
-
Regulatory Affairs Director
4 weeks ago
Melbourne, Victoria, Australia Heng & Hurst Full timeThis is a newly created senior leadership opportunity based in Melbourne, Australia, where you will have strategic and operational responsibility for a growing business. You will be part of a dynamic and entrepreneurial team, working closely with the CEO and other experienced executives to drive business growth through regulatory affairs.As the Head of...
-
Regulatory Affairs Specialist
4 weeks ago
Melbourne, Victoria, Australia DoorDash, Inc. Full timeAbout DoorDashWe're a technology and logistics company that empowers local economies by providing fast, reliable, and affordable delivery services to consumers. Our mission is to make it possible for anyone to get what they need in under an hour.Job OverviewWe're looking for a highly skilled Regulatory Affairs Specialist to join our Policy Development and...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeJoin a dynamic pharmaceutical company as they seek a highly skilled Regional Head of Regulatory Affairs & Pharmacovigilance. This newly created role offers a unique opportunity to shape regulatory strategy and ensure compliance across Australia, New Zealand, and regional markets.About the Company: As a recognised leader in multiple portfolios and specialty...
-
APAC Trade Regulatory Affairs Director
1 week ago
Melbourne, Victoria, Australia Mars Incorporated Full timeCompany Overview:Mars Incorporated is a global leader in the pet food industry, striving to build a better world for pets and people alike. Our commitment to innovation, quality, and sustainability drives our business forward. About the Role:We are seeking an experienced APAC Trade Regulatory Affairs Director to join our team in this critical role. The...
-
Regulatory Affairs Specialist
4 weeks ago
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeAbout Northern Trust:As a globally recognized and award-winning financial institution, Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions.We remain true to our enduring principles of service, expertise, and integrity, leveraging our financial experience and...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeCompany Overview:We are proud to partner with a dynamic biopharmaceutical company that has experienced great success, recognised as an innovative leader across multiple portfolios and specialty therapy areas. Their market-leading products have prolonged lives, enhanced the quality of life, and cured patients from debilitating diseases.About the...
-
Regulatory Affairs Expert in Melbourne
2 weeks ago
Melbourne, Victoria, Australia Gilead Sciences Full timeGilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. Our mission requires collaboration, determination, and a relentless drive to make a difference.As a knowledgeable professional, you will play a critical role in the discovery and development of...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeHealthcare Professionals Group is partnering with a leading biopharmaceutical company to find a Regional Head of Regulatory Affairs & Pharmacovigilance.About the OpportunityThis newly created role is ideal for an experienced leader in Regulatory Affairs and Pharmacovigilance, who will drive regulatory strategy and ensure compliance across Australia, New...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeAbout the RoleWe are seeking a highly skilled Regulatory Affairs Director to lead our team in ensuring compliance and shaping regulatory strategy across Australia, New Zealand, and regional markets.Key Responsibilities:Develop and execute regulatory strategies to drive product portfolio expansion.Oversee regulatory compliance across the ANZ and APAC regions...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeEstablish a Strong Regulatory Presence in ANZ and APACAbout the OpportunityThis newly created leadership role seeks an accomplished Head of Regulatory Affairs and Pharmacovigilance to lead and shape regulatory strategy, ensuring compliance across Australia, New Zealand, and regional markets. In this pivotal position, you will oversee both Regulatory Affairs...
-
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeAbout Northern Trust: A Financial Institution with a Global PresenceFounded in 1889, Northern Trust is a renowned Fortune 500 company that has been serving the world's most successful individuals, families, and institutions with innovative financial services and guidance.The Global Regulatory Affairs Office (GRAO) plays a crucial role in enhancing risk...
-
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeAbout Northern Trust Company AustraliaAs a leading global financial institution, Northern Trust is committed to delivering innovative solutions and expert guidance to its clients.Northern Trust has been in operation since 1889, serving the world's most sophisticated individuals, families, and institutions with exceptional service and integrity.The company's...
-
Planning Specialist
3 weeks ago
Melbourne, Victoria, Australia Public Sector People Full timeAbout the Role:Review and process planning applications in accordance with statutory requirements Provide clear and timely advice to stakeholders Ensure compliance with planning regulations and local policies We are seeking an experienced Planning Specialist to join our team. This is a 3-month temporary role, with the potential for extension, offering a...
-
Regulatory Affairs Specialist
3 weeks ago
Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full timeNorthern Trust Company Australia, a leading financial institution, seeks an experienced Regulatory Affairs Specialist to support the enhancement of our risk management and controls. This role sits within the Global Regulatory Affairs Office (GRAO) and involves providing subject matter expertise across a multi-year regulatory and risk program.The ideal...
-
Corporate Affairs Professional
3 weeks ago
Melbourne, Victoria, Australia Group People & Corporate Affairs Full timeAbout Asahi BeveragesWe are a leading multi-beverage organisation with a rich history, producing and marketing iconic beverage brands across Australia and New Zealand.Job SummaryWe seek a passionate Corporate Affairs Professional to support our Diversity, Equity & Inclusion (DE&I) initiatives, particularly in Aboriginal and Torres Strait Islander community...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeRegulatory Affairs and Pharmacovigilance Expert SoughtHealthcare Professionals Group is partnering with a leading biopharmaceutical company to find a highly experienced Head of Regulatory Affairs and Pharmacovigilance to lead their regulatory strategy and ensure compliance across Australia, New Zealand, and regional markets.About the RoleDevelop and execute...
-
Melbourne, Victoria, Australia Healthcare Professionals Group Full timeAbout the OpportunityHealthcare Professionals Group is partnering with a leading biopharmaceutical company to find a Regional Head of Regulatory Affairs & Pharmacovigilance. This newly created role offers an exciting opportunity to lead and shape regulatory strategy, ensuring compliance across Australia, New Zealand, and regional markets.Key...
