- Thermo Fisher is seeking an experienced Chemical Compliance professional to join the QARA team and work on Australia and New Zealand chemical regulatory submissions and compliance projects.
- The incumbent will provide strategic and tactical support to local commercial and global compliance teams
- The incumbent will work in the ANZ QARA department and will establish and execute the regulatory and compliance strategies, lead submissions and communicate with regulatory authorities in Australia and New Zealand .
- The incumbent will support product compliance with all applicable regulations including.Australia Pesticides and Veterinary Medicines AuthorityNew Zealand EPAAU/NZ Hazardous materials registrations,Import and export permits associated NZ Ministry of Primary Industry and AU Biosecurity Import Conditions regulations.Controlled substances (ODC)Others if appropriate
- The incumbent will technically support all aspects of chemical regulatory submissions and compliance in ANZ, including identifying National standards & guidance, and coordinating technical specifications for product submissions, to effectively manage regulatory risks for regulatory and compliance activities in ANZ.
- The incumbent will support and partner with the wider Thermo Fisher Scientific business on a variety of pre and post market activities, including product introduction, as required depending on regional priorities.
- Responsible for providing guidance to ensure that product regulatory compliance is planned, communicated and executed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
- Lead and drive regulatory compliance activities, including high quality chemical regulatory submissions, SDS & label management and chemical supplier management for the products circulated by the company in ANZ market to the following regulations including:Hazardous material compliance with Work Safe Australia and NZ EPA, including classification of hazardous materials in accordance to GHS standard.Chemical compliance with Australian Industrial Chemicals Introduction SchemeChemical compliance with Australian Pesticides and Veterinary Medicines AuthorityChemical compliance with New Zealand Inventory of ChemicalsBiological material compliance with Australia BICON, DAFF and New Zealand MPI
- Provide regulatory guidance to project teams and external partners, assisting the Company in achieving its business goals.
- Support global regulatory registration representatives for product global registration activities
- Perform regulatory assessment of new and changed products.
- Keep abreast of new or revised regulations, guidelines, and compliance guidelines.
- Conduct training and communicate appropriate materials, in order to support regulatory talent development.
- Assist Quality and Regulatory colleagues in the update, enhancement, and creation of internal policies and procedures.
- Support Post Market Surveillance of regulated products in Australia/New Zealand. Work with cross-functional teams, operations, and customers to resolve and implement corrective and preventive actions resulting from technical complaints.
- Participate in business meetings with potential new external partners.
- A minimum degree in Chemistry, Biology, Engineering or related science.
- Must have a minimum of 7 years' experience in a chemical regulatory compliance role.
- Must be well versed in the aspects of regulatory strategy creation, Chemical regulatory submission, Environmental management systems, and import/export requirements.
- Experience as an RA representative on project core teams providing active and successful regulatory guidance.
- Qualifications in Agriculture science, Agronomy or Chemistry would be highly beneficial
- Direct and positive experience in communicating with Regulatory Authorities and co-development partners.
- Regulatory review of SDS, labelling, etc.
- Demonstrate an understanding of GHS hazardous material classification process and a general understanding of dangerous goods regulations.
- Capacity to communicate regulations to technical functions within the company.
- High energy level; positive attitude; works well under stress, strong communicator.
- Hands-on, action-oriented, and able to effectively in a team.
- Continuous improvement minded.
- Able to work autonomously in a matrix-managed organization.
- Ability to provide solutions based on knowledge of regulation and industry experience.
- Willingness to travel (~10-15%)
- Comfortable with ambiguity and change
-
Customer Experience Specialist Iii
3 weeks ago
Thermo Fisher Scientific Scoresby, AustraliaWhen you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe Your work will have real-world impact, and you'll be supported in achieving your care ...
-
Compliance Specialist III
3 hours ago
Thermo Fisher Scientific Scoresby, Australia Full timeJob Description · How will you make an impact? · Thermo Fisher is seeking an experienced Chemical Compliance professional to join the QARA team and work on Australia and New Zealand chemical regulatory submissions and compliance projects. · The incumbent will provide strategic an ...
-
Product Specialist Iii
2 weeks ago
Thermo Fisher Scientific Melbourne, AustraliaAt Thermo Fisher Scientific, each one of our 125,000 extraordinary minds have a unique story to tell. Join us and lend to our mission—enabling our customers to make the world healthier, cleaner and safer. · When you're part of the team, you'll do important work Surrounded by coll ...
-
Compliance Specialist Iii
1 week ago
Thermo Fisher Scientific Scoresby, Australia**How will you make an impact?** · - Thermo Fisher is seeking an experienced Chemical Compliance professional to join the QARA team and work on Australia and New Zealand chemical regulatory submissions and compliance projects. · - The incumbent will provide strategic and tactical ...
-
Marketing Specialist Iii
4 days ago
Thermo Fisher Scientific Scoresby, AustraliaThis is an exciting opportunity for a Marketing expert in specialty diagnostics to elevate their career and join an established Marketing team. You would own the Specialty Diagnostic Group's (SDG) marketing strategy, with a focus on Microbiology, Clinical Diagnostics and Transpla ...
-
Product Specialist Iii
47 minutes ago
Thermo Fisher Scientific Scoresby, AustraliaPosition Purpose: · The Product Specialist is a commercial role, primarily responsible for driving profitable revenue and developing customer relationships and business within their respective territory and or market segment, for their relevant product portfolio. This includes de ...
-
Technical Application Specialist III
1 month ago
ThermoFisher Scientific Scoresby, Australia Paid WorkJob Description · At Thermo Fisher Scientific, each one of our 75,000 extraordinary minds has a unique story to tell. Join us and our singular mission—enabling our customers to make the world healthier, cleaner, and safer. · When you're part of the team at Thermo Fisher Scientifi ...
-
Technical Support Tier 2 Specialist Iii
4 weeks ago
Tesla Melbourne, AustraliaWhat to Expect · What You'll Do · - Responsibilities · - Evaluate the needs of customers and work in a creative, pro-active manner to resolve technical issues with the battery systems · - Educate our Installers and customers so they have optimal confidence in the operation of the ...
-
Business Service Specialist III
4 weeks ago
Farm Credit Services City of Melbourne, AustraliaFarm Credit of the Virginias is seeking to hire a Business Service Specialist III in its Warrenton, VA Branch. From your first day, you will be part of an engaged and customer-focused team · Our lending location teams rely on our Business Service Specialist to assess and fulfill ...
-
3rd Year
4 weeks ago
Employment Hero Mulgrave, Australia**_Are you an enthusiastic and driven individual? Are you committed to completing your Trade Qualification with a market leading company? _** · We have an exciting opportunity for an Electrical Apprentice to kick start their career in the Building and Construction Industry with T ...
-
Personal Care Assistant
3 weeks ago
Eastern Health Wantirna, AustraliaHealth Care Worker · Multiple Permanent, Full Time positions available · Comprehensive training and education program · $57,038.80 p.a. + super + salary packaging · Eastern Health · Eastern Health is one of Melbourne's largest public health services. We provide a range of emergen ...
-
Pharmacy Technician
3 weeks ago
Eastern Health Upper Ferntree Gully, AustraliaPermanent, Full Time position · Grade 1,2 or 3 · Monthly ADO · Work across different sites · Eastern Health · Eastern Health is one of Melbourne's largest public health services. We provide a range of emergency, surgical, medical and general healthcare services, including materni ...
-
Turf Specialist
2 weeks ago
Green Options Mulgrave, AustraliaFantastic opportunity for experienced Turfie · - Security and stability of well established business · - Fantastic culture and dynamic team · Green Options are a professional Landscape Management and Sports Turf Maintenance Company with long term contracts at Government, private ...
-
Gardener (South East)
1 week ago
Super Gardens Mulgrave, AustraliaSuper Gardens is Victoria's longest standing Commercial Grounds Maintenance, Landscape Construction and Turf Management specialists, servicing a diverse range of clients for over 33 years. · Now, part of the larger international Australasian Landscape Services (ALS Group comprisi ...
-
Personal Care Assistant/support Workers
2 weeks ago
Flexi Support Mulgrave, Australia**ABOUT US**: · Flexi Support have been providing in-home support across Melbourne for over 12 years and our services support a wide variety of clients, Flexi Support is a registered NDIS service provider. Flexi Support provide support services from self-funded clients to Governm ...
-
Villa Maria Catholic Homes Wantirna, AustraliaWantirna, VIC, Australia, 3152 · - Part time · - Add to favourites Favourite View favourites · - **Permanent Part-time role with a rate of $27-$30 per hour + super in Wantirna**: · - **Great culture with a supportive and inclusive environment**: · - **Excellent Not for Profit Sal ...
-
Personal Care Assistant
1 week ago
Eastern Health Wantirna, AustraliaHealth Care Worker / Personal Care Assistant · Permanent full · - and part-time positions, 53 to 76 hours per fortnight · Work close to home with easy car parking · Comprehensive training and education program · $57,038.80 pa + super + salary packaging pro rota for part time role ...
-
Personal Care Assistant/support Workers
2 weeks ago
Flexi Support Mulgrave, Australia**ABOUT US**: · Flexi Support have been providing in-home support across Melbourne for over 12 years and our services support a wide variety of clients, Flexi Support is a registered NDIS service provider. Flexi Support provide support services from self-funded clients to Governm ...
-
Leisure & Lifestyle Assistant
1 week ago
Eastern Health Wantirna, AustraliaCasual positions available · Wantirna Residential Care · $30.42 per hour + casual loading · Eastern Health · Eastern Health is one of Melbourne's largest public health services. We provide a range of emergency, surgical, medical and general healthcare services, including maternit ...
-
Personal Care Assistant/support Workers
1 week ago
Flexi Support Mulgrave, Australia**ABOUT US**: · Flexi Support have been providing in-home support across Melbourne for over 12 years and our services support a wide variety of clients, Flexi Support is a registered NDIS service provider. Flexi Support provide support services from self-funded clients to Governm ...
Compliance Specialist III - Scoresby, Australia - Thermo Fisher Scientific
Description
.
What will you do?
How will you get here?
Education
Experience:
Knowledge, Skills, Abilities