Job Title: Regulatory Compliance Specialist
The role of the Regulatory Compliance Specialist is to ensure that our organization's operations are in compliance with relevant regulations and standards. This involves a range of activities including audit planning, coordination and execution.
A key aspect of this role is to maintain professional expertise and knowledge of audit criteria, which includes internal company policies and procedures, as well as applicable local and international regulations, standards and guidelines. You will be responsible for monitoring industry trends with respect to regulatory agency findings, expectations and warning letters.
This position requires strong leadership qualities, excellent communication skills and the ability to collaborate effectively with various stakeholders. You should possess a deep understanding of regulatory compliance requirements in the Biotech/Pharmaceutical industry.
To succeed in this role you will need:
* Bachelor's degree or equivalent experience
* $8+ years' experience in Quality Management with prior supplier auditing experience; preferably within Aseptic Filling Operations.
, maintaining all required training on an annual basis, collaboration