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Regulatory Management Specialist

Seeking a Regulatory Specialist with an interest in extending their knowledge to include Trade Compliance in the Life Science industry. 


Who You Are:

  • Ensure compliance with all relevant regulations for the import, supply and export of chemicals, biologicals, medical devices and equipment
  • Manage day to day compliance screening queues in a timely manner (EUDs, Licences, import/export queues etc.);
  • Review and verify customer documents in accordance with all regulatory requirements for supply;
  • Classify products in accordance with local Customs and current regulations;
  • Work collaboratively with Customs Brokers to expedite customs clearance and troubleshoot issues;
  • Maintain business regulatory licenses to minimise supply chain disruption (i.e.  AU Depart of Agriculture, Dept of Health, DFAT, Customs, NZ MFAT, MPI, EPA/WorkSafe);
  • Undertake regular data management reviews for accuracy and relevance, update the necessary systems and share with stakeholders as required;
  • Liaise with local and global stakeholders including customers on regulatory related matters;
  • Provide support in regulatory management activities e.g. medical device product registration, training, surveillance and advocacy work;
  • Review, create and update training documents and SOPs;
  • Maintain accurate transactional records and submit regulatory and business reports as per required schedules.


What You Do:

  • Tertiary education in Science, preferably in a chemical or biotechnology discipline.
  • Experience in a regulatory and/or compliance function in a chemical environment would be preferred.
  • Knowledge in the regulations for import, supply and export of chemicals in Australia and New Zealand.
  • Experience in liaising and coordination with local regulatory agencies on licenses and registration matters.
  • Basic knowledge in SAP (ERP system).
  • Proficient in MS Office Applications especially MS Excel and Access.
  • Team player with good analytical and communication skills.
  • Able to work independently and demonstrate a willingness to challenge the status quo.
  • Meticulous, organized with a desire for continuous learning.
Job Requisition ID:  200647
Location:  Melbourne
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Manager, Biotech, Medical, ERP, SAP, Management, Science, Healthcare, Technology

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