Regulatory Affairs Specialist
1 week ago
The Senior Regulatory Affairs Associate will ensure successful regulatory submissions and approvals across Australia, New Zealand, and the Southeast Asia (SEA) region.
The role involves preparing and managing regulatory dossiers for submission to local authorities. This includes leading interactions with regulatory agencies, licensing partners, and external consultants to facilitate approvals.
Ongoing compliance is ensured by managing variations and renewals, while collaborating cross-functionally with Medical, Quality, and Commercial teams to support product launch activities.
- Prepare and manage regulatory dossiers for submission to TGA, Medsafe, and other regional authorities.
- Lead interactions with regulatory agencies, licensing partners, and external consultants to facilitate approvals.
- Manage ongoing compliance by overseeing variations and renewals.
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Regulatory Affairs Specialist
1 week ago
Melbourne, Victoria, Australia MyCareer+ Full timeAbout the CompanyMyCareer+ is an innovative leader in the medical and health industry, dedicated to improving lives through cutting-edge solutions. We continue to grow, seeking a Regulatory Affairs Specialist to join our dynamic team.Job DescriptionContent Review & Compliance: Analyze marketing materials, legal documents, and regulatory submissions to ensure...
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Regulatory Affairs Specialist
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Melbourne, Victoria, Australia Talent Full timeOur client is a leading government organization seeking a skilled Regulatory Affairs Specialist to support their team during the busy renewal period.About the RoleThe successful candidate will manage complex practising certificate applications, including foreign lawyer registrations, and provide advice on regulatory requirements and complex cases.Key...
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Regulatory Affairs Specialist
4 days ago
Melbourne, Victoria, Australia Hengandhurst Full timeSenior Regulatory Affairs Associate RoleThis is a unique opportunity for an experienced Senior Regulatory Affairs Associate to support the growth and commitment to delivering innovative therapies of a leading international biopharmaceutical company.The organisation has a strong presence across ANZ and SEA, known for its strategic approach to...
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Regulatory Affairs Expert
1 week ago
Melbourne, Victoria, Australia SDI Limited Full timeJob DescriptionWe are seeking a highly skilled Regulatory Affairs Expert to join our team at SDI Limited. As a key member of our regulatory affairs department, you will be responsible for managing high-level regulatory submissions and product registrations both locally and overseas.The ideal candidate will have excellent communication skills, a strong...
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Regulatory Affairs Expert
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Melbourne, Victoria, Australia Hengandhurst Full timeBiopharmaceutical Regulatory SpecialistHeng & Hurst is seeking an experienced Biopharmaceutical Regulatory Specialist to support its continued growth and commitment to delivering innovative therapies.The ideal candidate will have 5+ years' experience in regulatory affairs within the pharmaceutical industry, with strong knowledge of TGA guidelines, processes,...
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Regulatory Affairs Manager
2 days ago
Melbourne, Victoria, Australia SDI Limited Full timeCompany OverviewWe are a leading global business, established in 1972, specializing in Australian made and owned dental restorative products, teeth whitening, and small equipment. Our products are distributed in over 100 countries worldwide, with our global head office and manufacturing plant located in Melbourne. We have overseas branch offices and...
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Regulatory Affairs Expert
1 week ago
Melbourne, Victoria, Australia Hengandhurst Full timeResponsibilities and RequirementsThe Senior Regulatory Affairs Associate will be responsible for ensuring successful regulatory submissions and approvals across Australia, New Zealand, and the SEA region.The role requires preparation and management of regulatory dossiers for submission to TGA, Medsafe, and other regional authorities, as well as leading...
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Regulatory Affairs Lead
4 days ago
Melbourne, Victoria, Australia Stryker Group Part timeThe Regulatory Affairs Lead is responsible for overseeing and driving key regulatory activities for Stryker South Pacific, ensuring compliance with relevant regulations and legislation.This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of escalation...
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Regulatory Affairs Director
4 days ago
Melbourne, Victoria, Australia Gilead Sciences, Inc. Part timeAbout UsGilead Sciences, Inc. is a leading biopharmaceutical company dedicated to developing innovative therapies that improve patient lives. With over 35 years of experience, we have tackled some of the world's most pressing health challenges, including HIV, viral hepatitis, COVID-19, and cancer.Job DescriptionWe are seeking an experienced Regulatory...
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Regulatory Affairs Specialist
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Melbourne, Victoria, Australia eFinancialCareers Ltd. Full timeAs a Regulatory Counsel, you will be working at the forefront of regulatory affairs for Binance, a leading global blockchain ecosystem. Our company is trusted by over 250 million people in 100+ countries for our industry-leading security, user fund transparency, trading engine speed, deep liquidity, and an unmatched portfolio of digital-asset products.You...
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Melbourne, Victoria, Australia Telecommunications Industry Ombudsman Full timeWe are looking for a seasoned Telco Regulatory Specialist to join our team at the Telecommunications Industry Ombudsman (TIO). As a key member of our Legal, Policy and Regulatory Affairs Group (LPRA), you will provide critical legal advice to the Ombudsman, Executive Leadership Team, and wider functions of the TIO. In this role, you will have opportunities...
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Associate Director Regulatory Affairs
6 days ago
Melbourne, Victoria, Australia Hengandhurst Full timeAssociate Director Regulatory AffairsHeng & Hurst is seeking an Associate Director Regulatory Affairs to join our team in Melbourne.The ideal candidate will have strong leadership experience in regulatory affairs within the pharmaceutical industry, with a proven track record of ensuring successful regulatory submissions and approvals across Australia, New...
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Senior Regulatory Affairs Associate
3 weeks ago
Melbourne, Victoria, Australia Hengandhurst Full timeSenior Regulatory Affairs Associate | multiple launches | MEL basedJoin to apply for the Senior Regulatory Affairs Associate | multiple launches | MEL based role at Heng & Hurst.Join a leading international biopharmaceutical company who is seeking an experienced Senior Regulatory Affairs Associate to support its continued growth and commitment to delivering...
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Senior Regulatory Affairs Associate
6 days ago
Melbourne, Victoria, Australia Hengandhurst Full timeSenior Regulatory Affairs Associate | multiple launches | MEL basedJoin to apply for the Senior Regulatory Affairs Associate | multiple launches | MEL based role at Heng & Hurst.Join a leading international biopharmaceutical company who is seeking an experienced Senior Regulatory Affairs Associate to support its continued growth and commitment to delivering...
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Regulatory Affairs Lead
4 days ago
Melbourne, Victoria, Australia Stryker Group Part time**Job Description:**Stryker Group is seeking a highly experienced Regulatory Affairs Lead to oversee and drive key regulatory activities, ensuring compliance with relevant regulations and legislation.This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point...
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Melbourne, Victoria, Australia Mondelēz International Full timeJob DescriptionAre You Ready to Make It Happen at Mondelēz International?Join our Mission to Lead the Future of Snacking. Make It Matter.Mondelēz International empowers people to snack right in over 150 countries around the world. We're leading the future of snacking with iconic global and local brands such as Oreo, Cadbury, Philadelphia, Pascall, The...
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Regulatory Affairs Lead Manager
2 days ago
Melbourne, Victoria, Australia Gilead Sciences Full timeAbout the RoleThe Associate Director, Regulatory Affairs will be responsible for leading projects for the Regulatory Affairs team in the ANZ affiliate. This individual will work closely with cross-functional colleagues to ensure Gilead complies with country-specific legislations and regulations linked to the MA / local license as MA Holder or as local legal...
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Regulatory Affairs Manager
3 weeks ago
Melbourne, Victoria, Australia ClearCompany Full timeRole Focus: Drive regulatory strategy and market development initiatives, influencing policy and industry engagement to support business objectives.Role Snapshot:Competitive salary with career progression in a leading energy provider.Develop and execute regulatory strategies to navigate evolving energy markets.Engage with policymakers, regulators, and...
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Regulatory Affairs Manager
4 weeks ago
Melbourne, Victoria, Australia ClearCompany Full timeRole Focus: Drive regulatory strategy and market development initiatives, influencing policy and industry engagement to support business objectives. Role Snapshot: Competitive salary with career progression in a leading energy provider. Develop and execute regulatory strategies to navigate evolving energy markets. Engage with policymakers, regulators,...
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Regulatory Affairs Senior Manager
2 days ago
Melbourne, Victoria, Australia Gilead Sciences, Inc. Full timeAt Gilead Sciences, Inc., we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe.About the Role:The Associate Director, Regulatory Affairs...