Compliance Specialist III

at  Thermo Fisher Scientific

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 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 Authority
• New Zealand EPA
• AU/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

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• 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.

EDUCATION

• A minimum B.Sc. degree in Chemistry, Biology, Engineering or related science.

EXPERIENCE:

• 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.

KNOWLEDGE, SKILLS, ABILITIES

• 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

• 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 Scheme
• Chemical compliance with Australian Pesticides and Veterinary Medicines Authority
• Chemical compliance with New Zealand Inventory of Chemicals
• Biological 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.