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SENIOR REGULATORY AFFAIRS SPECIALIST

Analyze and/or assist in the analysis of scientific content of registration packages. Prepare and submit regulatory submissions to the TGA/Medsafe or other associated regulatory bodies. Review and approve artwork and packaging cha...

CompanyBoehringer Ingelheim
AddressSydney, NSW
CategoryLegal
SalaryPermanent
Date Posted a month ago See detail

Senior Regulatory Affairs Specialist

Boehringer Ingelheim

Sydney, NSW

Permanent

Analyze and/or assist in the analysis of scientific content of registration packages. Prepare and submit regulatory submissions to the TGA/Medsafe or other associated regulatory bodies. Review and approve artwork and packaging cha...

Senior Regulatory Affairs Specialist

Boehringer Ingelheim

Macquarie Park, NSW

Analyze and/or assist in the analysis of scientific content of registration packages. Prepare and submit regulatory submissions to the TGA/Medsafe or other associated regulatory bodies. Review and approve artwork and packaging cha...

Senior Regulatory Affairs Specialist

Boehringer Ingelheim

Sydney, NSW

Analyze and/or assist in the analysis of scientific content of registration packages. Prepare and submit regulatory submissions to the TGA/Medsafe or other associated regulatory bodies. Review and approve artwork and packaging cha...

Senior Regulatory Affairs Specialist

Bristol Myers Squibb

Mulgrave, VIC

Provide informed, accurate regulatory guidance in quality, safety, compliance and clinical trial matters. Develop and recommend regulatory strategies in consultation with stakeholders, and Regulatory Affairs team. Manage appropria...

Senior Regulatory Affairs Specialist

Bristol-Myers Squibb

Australia

Permanent

We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. The scope of the role includes supporting a dive...

Regulatory Affairs Specialist - 12-month contract New

Cook Medical

Eight Mile Plains, QLD

Perform all tasks in accordance with the Quality Management System to a competent standard. Maintain design dossiers, technical files and other regulatory documents. Maintain Regulatory Affairs project databases and systems which...

Regulatory Affairs Specialist New

Australia Biotechnology Manufacturing

Keysborough, VIC

Listing of the new Products. Variations including labelling changes, safety updates. MaintenanceofMarketingAuthorisationsincludingrenewals. Deficiencyresponsestoauthorities. GMP Clearances. TGO 91 and 92. Interfacingwith...

Senior Regulatory Affairs Consultant New

Healthcare Professionals Group

Sydney, NSW

Permanent

A role for an experienced Regulatory Affairs professional. Opportunity for career development and progression within the team. Part time option available and competitive salary package on offer. Ensuring timely submission and resp...

Senior Manager, Regulatory Affairs - 12-month opportunity New

Aesop

Melbourne, VIC

Permanent

Lead regional Regulatory Affairs function over the product lifecycle from pre-market concept, product development, registration, artwork and post-market advertising compliance and vigilance activities. Manage and support the Risk...

Senior External Affairs Specialist

Synergy

Perth, WA

Permanent

Proactively lead the delivery of external corporate reporting and publications, working with the Media & External Affairs team to deliver external publications. Provide communications support to executive leadership team, includin...

Senior Regulatory Affairs Associate

Rapid Response Revival

Riverwood, NSW

Based in Riverwood, we design, manufacture and supply automatic external defibrillators (AEDs) for multiple global markets with our priority centered around developing AED solutions that make portable defibrillation affordable, a...

ANZ- Regulatory Affairs Specialist

Pepsico

Chatswood, NSW

Engage with R&D team and be able to acquire required regulatory package (product composition, ingredient specification, labelling information. etc.) from the data system. Assess and ensure compliance of finished products formula a...

Senior Regulatory Specialist

Brunel

Melbourne, VIC

Risk MonitoringMonitor risk levels and report potential risks to senior management and other stakeholders Risk Management Policies and ProceduresDevelop and implement risk management policies and procedures to identify, assess,...

Regulatory Affairs & Quality Assurance Specialist | Medical Devices | SYD

Heng & Hurst

Sydney, NSW

Ensure ongoing compliance and maintenance of product registration and manage submissions for new, variation, and renewal approvals. Maintain up-to-date product registration documentation and review and approve advertising and labe...

Senior Environmental Regulatory Approvals Specialist

Mark Bouw Group Pty Ltd

Melbourne, VIC

Lead the preparation and submission of regulatory approval applications for various projects and operational changes, ensuring compliance with all relevant legislation and standards. Conduct environmental impact and risk assessme...

Senior Regulatory Affairs Associate

Msd

Macquarie Park, NSW

Permanent

Develop and maintain effective working relationships with all members of Product Lifecycle Planning team.Actively collect, analyse and disseminate regulatory intelligence and other information and formulate strategies for best pra...

Regulatory Affairs Specialist, Advanced Surgery

Baxter

Old Toongabbie, NSW

Permanent

This is where you can do your best work.Join us at the intersection of saving and sustaining liveswhere your purpose accelerates our mission.The companys global footprint and the critical nature of its products and services play...

Senior Regulatory Affairs Associate

Msd

Macquarie Park, NSW

Looking for an exciting opportunity as a Senior Regulatory Affairs Associate with an Innovator Research-intensive biopharmaceutical Company?. Permanent Full-time position with competitive renumeration and benefits. Location: Sydne...

Senior Regulatory Affairs Associate

Msd

Macquarie Park, NSW

Looking for an exciting opportunity as a Senior Regulatory Affairs Associate with an Innovator Research-intensive biopharmaceutical Company? Permanent Full-time position with competitive renumeration and benefits Location: Sydney,...

Regulatory Affairs Specialist

Msd

Macquarie Park, NSW

Looking for a different challenge as a Regulatory Affairs Specialist whereby you can still utilise your skills?. Permanent Full-time position with competitive renumeration and benefits. Ideally based from Sydney Australia, also op...

Senior Regulatory Affairs Associate

Astrazeneca

Sydney, NSW

Financial and Market AnalysisConduct financial analysis and market research to inform investment and capital allocation decisions Investment Stakeholder PresentationsPrepare and present to clients and internal stakeholders, incl...

Regulatory Affairs Specialist

Merck & Co., Inc.

Macquarie Park, NSW

Looking for a different challenge as a Regulatory Affairs Specialist whereby you can still utilise your skills? Permanent Full-time position with competitive renumeration and benefits Ideally based from Sydney Australia, also open...

Senior Regulatory Affairs

Awx Executive

Melbourne, VIC

To develop a clear global regulatory strategy for all product development and commercialisation plans. Lead product regulatory approval projects across Australia, EU and the US. Prepare and maintain medical device files for submis...

Senior Regulatory Affairs

Awx

Melbourne, VIC

$100,000-130,000 per year

To develop a clear global regulatory strategy for all product development and commercialisation plans. Lead product regulatory approval projects across Australia, EU and the US. Prepare and maintain medical device files for submis...

Regulatory Affairs Specialist (Sponsorship Available)

Atlamgroup

Macquarie Park, NSW

Permanent Full-time position with competitive renumeration and benefits Ideally based from Sydney Australia, also open to NZ located applicants Hybrid, work from home and office environment, with a dedicated and welcoming team Joi...

Senior Aviation Regulatory Specialist (Surveillance)

Airservices Australia

Queensland

Two Year Fixed Term Contract. Hybrid Work (including WFH) & Flexibility. Sydney, Melbourne, Brisbane, or Canberra Location. Provide subject matter expertise in aviation regulation compliance across the value chain. Develop trusted...

Senior Aviation Regulatory Specialist (Surveillance)

Airservices Australia

Brisbane, QLD

Two Year Fixed Term Contract. Hybrid Work (including WFH) & Flexibility. Sydney, Melbourne, Brisbane, or Canberra Location. Provide subject matter expertise in aviation regulation compliance across the value chain. Develop trusted...

Senior Manager, Regulatory Affairs

Qbe Insurance

Sydney, NSW

Join a dynamic, supportive team. Part-Time, Permanent Opportunity (Open to 3-4 days a week). Sydney, New South Wales. Leadership. As a senior member of the Regulatory team, work alongside the Head of Regulatory, to influence and m...

Senior Aviation Regulatory Specialist (Surveillance)

Airservices

Victoria

Two Year Fixed Term Contract. Hybrid Work (including WFH) & Flexibility. Sydney, Melbourne, Brisbane, or Canberra Location. Provide subject matter expertise in aviation regulation compliance across the value chain. Develop trusted...

Senior Manager, Regulatory Affairs

Qbe Insurance Group Limited

Sydney, NSW

Join a dynamic, supportive team. Part-Time, Permanent Opportunity (Open to 3-4 days a week). Sydney, New South Wales. Leadership. As a senior member of the Regulatory team, work alongside the Head of Regulatory, to influence and m...