Principal Regulatory Affairs Specialist
About the Role:
* This role will involve coordinating and preparing document packages for regulatory submissions from all areas of the organization.
* You will lead or compile materials required in submissions, license renewal and annual registrations.
* Your expertise will be utilized to recommend changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance.
* You will stay up-to-date with regulatory procedures and changes.
* Interaction with regulatory agencies on defined matters may also be involved.
Key Responsibilities:
* Cordinate regulatory submissions and ensure compliance with relevant regulations.
* Develop and maintain knowledge of regulatory requirements and industry best practices.
* Liaise with internal stakeholders to gather necessary information for regulatory submissions.
* Monitor and improve tracking/control systems to ensure efficient and compliant processes.
Requirements and Qualifications:
* A University Degree is required, along with a minimum of 7 years of relevant experience.
* Advanced degree holders with at least 5 years of experience are also eligible.
* Broad knowledge of project management can be beneficial.
* Mastery of a specialty area and full knowledge of industry practices are typically obtained through advanced education combined with experience.
What We Offer:
* A challenging and rewarding role that allows you to utilize your expertise in regulatory affairs.
* The opportunity to work with a dynamic team and contribute to the success of the organization.
* Professional development and growth opportunities.