Current jobs related to Regulatory Affairs Specialist - Melbourne - ProductLife Group


  • Melbourne, Australia On Q Recruitment Full time

    Full time permanent position that can be based in Melbourne or Sydney - Hybrid working arrangement (2 days in the office and 3 days from home) - Be part of a fast growing global medical device company Wouldn't you want to utilise your strong medical device regulatory knowledge to be part of an ever fast growing global innovative company? - Full time...


  • Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Manufacturing Organisation - Regulatory Support for Products within Asia Pacific Markets - Melbourne Metro Area - Hybrid Role - WHF & Site based **About the Company**: Operating as a progressive and highly respected pharmaceutical manufacturing organisation, our client is well known for its operational excellence, passion for...


  • Melbourne, Victoria, Australia MyCareer+ Full time

    About 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...


  • Melbourne, Australia KE Select Full time

    Leadership Position in the Regulatory Affairs Department - IVD Medical Devices and EMCD Regulation - International Manufacturer of Clinical Diagnostic Instruments **Regulatory Affairs Manager (VIC) | IVD Medical Devices** *** **About the Company** This is your opportunity to be a part of a global manufacturer of clinical diagnostics laboratory...


  • Melbourne, Victoria, Australia Talent Full time

    Our 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...


  • Melbourne, Victoria, Australia Hengandhurst Full time

    Senior 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...


  • Melbourne, Victoria, Australia SDI Limited Full time

    Job 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...


  • Melbourne, Victoria, Australia Hengandhurst Full time

    Biopharmaceutical 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,...


  • Melbourne, Victoria, Australia Shell Energy Operations Pty Ltd Full time

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Compliance Advisor to support our Manager of Regulatory and Compliance in compliance risk mitigation, analytical risk identification, and compliance reporting. As a key member of our team, you will develop and implement compliance objectives and processes within the Compliance Framework.


  • Melbourne, Victoria, Australia SDI Limited Full time

    Company 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...


  • Melbourne, Victoria, Australia Hengandhurst Full time

    Responsibilities 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...


  • Melbourne, Victoria, Australia Hengandhurst Full time

    Key ResponsibilitiesThe 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...


  • Melbourne, Victoria, Australia Stryker Group Part time

    The 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...


  • Melbourne, Victoria, Australia Gilead Sciences, Inc. Part time

    About 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...


  • Melbourne Eastern Suburbs, Australia HAYS Full time

    Regulatory Affairs Manager for global medical device company based in Melbourne. **Your new company** This is a global medical device/diagnostic company based in Melbourne looking for a Regulatory Affairs Manager to join there team and support global registrations. **Your new role** Your new role will be managing a team of regulatory professional and...


  • Melbourne, Victoria, Australia Hengandhurst Full time

    Associate 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...


  • Melbourne, Victoria, Australia Telecommunications Industry Ombudsman Full time

    We 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...


  • Melbourne, Victoria, Australia eFinancialCareers Ltd. Full time

    As 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...


  • Melbourne, Victoria, Australia Hengandhurst Full time

    Senior 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...


  • Melbourne, Victoria, Australia Hengandhurst Full time

    Senior 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...

Regulatory Affairs Specialist

1 month ago


Melbourne, Australia ProductLife Group Full time

Specific Activities and Responsibilities:
Must have expertise in Health Authority communications for Initial filings, LCM Activities and for variation submissions.Must have experience and thorough knowledge of the process of submissions at HA without missing any detail or deadline.Must be competent with the current changes and regulations from the HA.Will be able to provide local support for clients submission filings specially in AU/NZ.

Required education:
Required experience:
minimum 5 years in Regulatory Affairs

Required technical skills:
Basic computer skills including MS Word, MS Excel, MS Power point along with proficiency in client communication, understanding, acknowledging and reverting the mails on time.

Additional experience and/or skills:
Must be equipped with regulatory knowledge for APAC region in terms of Initial filing, LCM management, variation submissions with HA.

**Job Type**: Freelance

Pay: $255,682.67 - $1,179,809.79 per year

**Benefits**:

- Work from home

Schedule:

- 10 hour shift