Position:  Regulatory Compliance Specialist
Location:  Santiago, Chile
Job Id:  1269
# of Openings:  1

Regulatory Compliance Specialist-  Santiago, Chile
 
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 Regulatory Affairs Director, the Regulatory Specialist is responsible for interacting with regulatory agencies on medical cannabis regulations throughout Latin America. The incumbent will assess the evolving regulatory landscape and develop strategies for product registration. Ensures that the company generates and maintains product documentation required for regulatory compliance. The incumbent is responsible for drafting, compiling and controlling product development documentation to support international product registration and market launch initiatives. 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 Latin American market
  • Generate accurate and up-to-date regulatory submissions, compliant with regional regulatory agencies
  • Work closely and collaboratively with the Clinical Research Team to ensure that Tilray is maximally leveraging clinical trial data for revenue generation via registrations
  • Generate accurate and up-to-date product quality documents, compliant with different Latin American regulators, for a variety of functions, including Chemistry, Manufacturing and Controls (CMC) sections and Summary of Product Characteristics (SmPOC)
  • Work closely and collaboratively with the Quality Team to ensure that all product quality documentation has the applicable data set for compliance
  • Understand and evaluate each market’s medical cannabis regulations to develop innovative strategies for clinical trials to allow registration
  • Assemble and maintain registration documentation in the Document Library in accordance with document control procedures
  • Provide GMP- and ICH-related regulatory advice to other departments (Facilities, Procurement, Manufacturing, Logistics, etc.) and advise on incorporating regulatory requirements into QMS documentation.
  • Perform internal departmental regulatory compliance audits to facilitate sustained conformance
  • Review product labels or other required documentation to ensure compliance with International requirements
  • Other duties as assigned
 

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 in regulatory affairs within the pharmaceutical industry
  • Thorough knowledge of Latin American regulations related to product quality (GMP, ICH) as well as ability to interpret changing policies and guidelines
  • Proven ability to generate a variety of technical product quality documentation
  • Proficiency in English and Spanish; Some knowledge of Portuguese preferred
  • Willing to travel, approx. 20%
It is preferred that applications are submitted in English
 
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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