Position:  Regulatory Compliance Specialist
Location:  Sydney, Australia, Australia
Job Id:  1270
# of Openings:  1

Regulatory Compliance Specialist -  Sydney, Australia
 
Tilray is a federally licensed producer of medical cannabis. We are committed to setting the gold standard of care and excellence in our industry. We believe that commitment starts with a great work environment and benefits for our associates.
 
Looking to develop your career at the forefront of a rapidly expanding industry?
 
 
Reporting to the VP of Regulatory and Medical Affairs, the Regulatory Affairs (RA) Specialist will be responsible for interacting directly with regulatory bodies for the planning, management, coordination and execution of regulatory submissions. The primary markets for this candidate will be Australia and New Zealand, the candidate will also assist with the Market Access strategy and support of RA activities within the JAPAC Region. 
 
The RA Specialist will support the Global team with Clinical Trial Applications (CTA) and New Drug Applications (NDA), as well as amendments, and/or Marketing Authorization preparations. The candidate will develop a comprehensive Regional Market Access/filing plan in conjunction with the Global team.  The RA Specialist will work with the Global team to improve on management systems for the compilation of submission documents, tracking of submissions and approval dates, and response to question preparation.  The RA Specialist must adhere to corporate standards and all local regulatory requirements.
 
The ideal candidate is highly organized, has excellent regulatory strategic thinking, adapts to changing priorities and demonstrates excellent communication, project management and problem-solving skills.

Role and Responsibilities

  • Assess regulatory environments and requirements of the ANZ market, as well as new and emerging markets in JAPAC region
  • Generate accurate and up-to-date regulatory submissions, compliant with regional regulatory agencies. Execute the preparation of CTA/NDA and other filings
  • Work closely and collaboratively with the Clinical Research Team to ensure that Tilray is maximally leveraging clinical trial data for revenue generation via registrations
  • Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies
  • Ensure that scientific data supporting submissions comply with applicable regulations and guidelines
  • Organize and prepare investigational product amendments and post-market supplements, in collaboration with the Global team, providing regulatory input to product lifecycle planning
  • Understand, investigate and evaluate regulatory history and background of class, disease/ therapeutic/diagnostic context to assess regulatory implications for approval
  • Negotiate with regulatory authorities during the development and review process to ensure submission approval
  • Conduct contingency regulatory planning and risk assessment for regional development and regulatory interaction strategies
  • Collaborate closely with regulatory specialists in other regions to harmonize submissions as much as possible
  • Review current SOP’s and develop new SOP’s ensuring compliance with archiving, tracking, and monitoring metrics
  • Perform internal departmental regulatory compliance audits to facilitate sustained conformance
  • Review and compare regulatory outcomes with initial product concepts to generate recommendations on future actions
  • Review product labels to ensure compliance with International regulatory requirements
  • Review regulatory aspects of contracts
  • Provide regulatory input for product recalls and recall communications
  • Identify and support country-specific regulatory partners in the JAPAC region
  • Contribute to the Regional Market Access Strategy

Qualifications and Education Requirements

  • B.Sc. degree in Biological/Life Sciences/Bioengineering (Pharmacology, Molecular Biology, Biology, Chemistry) or extensive experience and related training
  • Post-graduate Regulatory Certification preferred
  • 3-5 years’ experience working within a pharmaceutical company on clinical development of products and regulatory affairs
  • Thorough knowledge of Therapeutic Goods Administration (TGA) regulations related to registrations, with the ability to adapt these traditional requirements for a novel industry
  • Significant experience interacting with TGA on clinical data component of registrations
  • Proven ability to generate a clinical data sections of registration submissions
  • Willing to travel, approximately 10%
 
Tilray welcomes applications from all qualified individuals and is committed to employment equity and diversity in the workplace.
Accommodations are available for applicants with disabilities throughout the recruitment process. If you require accommodations for interviews or other meetings, please advise when submitting your application.

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