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REGULATORY AFFAIRS OFFICER

Preparation and submission of marketing authorization applications. Obtain regulatory approvals. Collation of information for dossiers. Manage national regulatory commitments and submissions;. Provide regulatory advice to internal...

Company4C Recruitment Solutions
AddressNew South Wales
CategoryLegal
SalaryPermanent
Date Posted a month ago See detail

Regulatory Affairs Officer

4C Recruitment Solutions

New South Wales

Permanent

Preparation and submission of marketing authorization applications. Obtain regulatory approvals. Collation of information for dossiers. Manage national regulatory commitments and submissions;. Provide regulatory advice to internal...

a month ago seen See more...

Regulatory Affairs Manager

I-Pharm Consulting

Sydney, NSW

Permanent

Identify, prepare and submit documentation to the relevant region regulatory bodies; including but not limited to the Therapeutic Goods Administration, FDA, EU and UK Rep. Provide regulatory support for medical, marketing and othe...

a month ago seen See more...

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...

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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...

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Regulatory Affairs Intern

Atlamgroup

Sydney, NSW

We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs. Viatris empowers people worldwide to live healthier at every stage of life.We do so via: Access Providing high...

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Regulatory Affairs, Senior Specialist

Edwards Lifesciences

Ryde, NSW

Assist RA Director with developing in-country annual strategy on new product introduction pipeline.. Prepare and review product registrations for new products & change notifications to existing products, within agreed timeline in...

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Regulatory Affairs Intern

Viatris

Sydney, NSW

Work with cross-functional teams within the business to provide our customers access to high quality medicines. Maintain compliance with relevant regulations and codes. Assist with regulatory activities within required timeframes....

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Regulatory Affairs Intern

Viatris

Sydney, NSW

Work with cross-functional teams within the business to provide our customers access to high quality medicines. Maintain compliance with relevant regulations and codes. Assist with regulatory activities within required timeframes....

a month ago seen See more...

Senior Regulatory Affairs Associate

Melrose Health

Mount Waverley, VIC

Providing regulatory guidance for all products, both complementary medicine and food. Formulation and label reviews.. Completing and maintaining TGA listings. Assisting with permitted indications determinations. Developing claims...

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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 open...

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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 appropr...

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Regulatory Affairs Manager

I-Pharm Consulting

Sydney, NSW

$120,000 - $150,000 a year

Identify, prepare and submit documentation to the relevant region regulatory bodies; including but not limited to the Therapeutic Goods Administration, FDA, EU and UK Rep. Provide regulatory support for medical, marketing and othe...

a month ago seen See more...

Quality and Regulatory Affairs Manager

Accord Healthcare Australia

Melbourne, VIC

Set-up and maintain local regulatory systems and processes, including registration database. . Review and audit CTD dossiers made available from global organisation. and provide input into the registration strategy to build the p...

a month ago seen See more...

Senior Regulatory Affairs Associate

Astrazeneca

Macquarie Park, NSW

Science related Tertiary qualifications. Experience in a (Senior) Regulatory Affairs role from within the pharmaceutical industry in Australia/New Zealand. Experience preparing category 1 applications. Working relationships with t...

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Regulatory Affairs Associate

U&U Recruitment Partners

Melbourne, VIC

$100,000 - $115,000 a year

Preparation and submission of marketing authorisation applications in global markets, including USA and Australasia;. Obtain regulatory approvals globally for designated product portfolio;. Manage national regulatory commitments a...

a month ago seen See more...

Freelance/Contractor Regulatory Affairs Associate

Avicenna Consulting

Canberra, ACT

assessing new and existing products to determine regulatory positioning. advising on actions that need to be taken to place a product in a certain regulatory category. undertaking literature reviews and assessments of evidence to...

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Regulatory Affairs and Quality Assurance Manager

Hays Recruitment

Sydney, NSW

Tertiary qualified in a science-related field.. Demonstrated experience in Regulatory Affairs. Experience with Prescription products. Management experience is preferable. Excellent communications skills....

a month ago seen See more...

Principal Regulatory Analyst

Agency : Economic Regulation Authority

Perth, WA

Great work/life balance with flexible start/finish times. 37.5 hours working week as standard. Working from home option. Flexible working arrangements (part-time, job share). Award-based salary with annual increments within award...

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Quality Assurance and Regulatory Affairs Manager

Resonance Health Analysis Services

Burswood, WA

Create and upkeep of documentation to ensure compliance to ISO13485 and ISO17025, ICH-GCP, GCLP, GMP. Ensure the Resonance Health meets applicable regulatory & statutory requirements in all areas (Australia, USA, Europe, United Ki...

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Regulatory Affairs Lead

Icare

Sydney, NSW

12-month fixed-term role & package starts at 139k base + super + benefitsHybrid/flexible working model, high-performing & engaged team cultureCan work in Sydney-CBD, Parramatta, Newcastle, Gosford or Wollongong About the Role12-mo...

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Regulatory Affairs Intern

Viatris Inc.

Sydney, NSW

Work with cross-functional teams within the business to provide our customers access to high quality medicines. Maintain compliance with relevant regulations and codes. Assist with regulatory activities within required timeframes....

2 months ago seen See more...

Regulatory Affairs, Senior Specialist

Edwards Lifesciences Corp

North Ryde, NSW

Assist RA Director with developing in-country annual strategy on new product introduction pipeline. Prepare and review product registrations for new products & change notifications to existing products, within agreed timeline in o...

2 months ago seen See more...

Document Controller & Regulatory Affairs

Hays

Cairns, QLD

Monitoring the inbox and prioritising urgent tasks. Actioning important document change requests. Tackling urgent items and tasks as directed by the wider team involving reviewing legislation....

2 months ago seen See more...

Quality and Regulatory Affairs Manager

Accord Healthcare Australia

Sydney, NSW

Set-up and maintain local regulatory systems and processes, including registration database. . Review and audit CTD dossiers made available from global organisation. and provide input into the registration strategy to build the p...

2 months ago seen See more...

Document Controller & Regulatory Affairs

Hays Recruitment

Cairns, QLD

Monitoring the inbox and prioritising urgent tasks. Actioning important document change requests. Tackling urgent items and tasks as directed by the wider team involving reviewing legislation....

2 months ago seen See more...

Regulatory Affairs Manager

Fuse Recruitment

Melbourne, VIC

Play an integral role in diversifying the companys product range. Work in a state-of-the-art facility with a high-performing team. Be part of a fabulous group of people Fantastic, diverse and inclusive culture. On-site parking....

2 months ago seen See more...

Global Regulatory Affairs CMC Manager (100%) in the Albumins Team

Csl - Australia

Broadmeadows, VIC

Competitive

Develops and executes Global Regulatory strategies in close collaboration with the site Quality and Manufacturing Departments and with regional regulatory experts to license product changes. Develops and executes Global Regulatory...

2 months ago seen See more...

Regulatory Affairs Manager - Scams

Anz

Melbourne, VIC

Oversee and manage regulatory engagements and reviews related to external fraud, scheme disputes and scam management. Develop and maintain strong relationships with internal stakeholders including public policy, regulatory complia...

2 months ago seen See more...

Senior Regulatory Affairs Specialist

Universal Biosensors

Rowville, VIC

$110,000-140,000 per year

Lead product regulatory approval projects for key markets, including EU and US. Responsible for clinical & vigilance aspects of new and 'in-market' products. Prepare and maintain Medical Device Files for submission to regulatory a...

2 months ago seen See more...

Regulatory Affairs Manager - Scams

Anz

Melbourne, VIC

Oversee and manage regulatory engagements and reviews related to external fraud, scheme disputes and scam management.. Develop and maintain strong relationships with internal stakeholders including public policy, regulatory compli...

2 months ago seen See more...

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