The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
The Quality Assurance and Regulatory Associate oversees the development implementation and maintenance of quality assurance systems and activities to ensure compliance with GxP and applicable international regulatory standards. In a regulatory capacity, the Associate will also assist in the preparation and maintenance of regulatory submissions and communications. To this end, the Associate will need to keep abreast of evolving changes in the regulatory environment, compliance policies and procedures.
This unique role offers an opportunity for the successful candidate to operate within a small multi-functional business environment, requiring the ability to work in a flexible, adaptive manner, liaising with staff and external resources to achieve clear deliverables in occasionally tight timelines.
We offer a competitive salary, excellent benefits and career development opportunities.
Duties and Responsibilities:
Coordinates and prepares document packages for regulatory submissions to ensure alignment with registration requirements. Compiles all materials required in submissions, licence renewals and annual registrations.
Recommends changes for labelling, manufacturing, marketing and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems. Tracks progress towards regulatory submissions within established timelines.
Recommends regulatory strategies for approval and may directly interact with agencies on defined matters.
Maintain regulatory correspondence documentation
Contribute to regulatory budget management
Follow emergence of new regulatory standards and guidelines that may impact Eupraxia products
Perform regulatory intelligence on competitor products.
Assists the organization with compliance issue management and leads the ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards.
Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them.
Coordinate external audits, internal audits and gap analysis
With guidance, create, maintain and evolve the Quality Management system; oversee and maintain hard copies and electronic databases as appropriate
Create and maintain the Quality Plan for product candidates
Coordinate and minute meetings for the Quality Management Committee and Management Review Meeting(s)
Oversee Document Control: creation, revision, review, approval and control of documents
Review of complaint files, Nonconformity Documentation forms, and corrective/preventative (CAPA) actions
Maintains the internal training system on quality assurance requirements, processes, and procedures. Manages the onboarding training of new employees as it pertains to the Quality System.
Recognized degree in relevant field (health sciences preferred)
2+ years of relevant experience (or demonstrated abilities) in a pharmaceutical environment
RAC designation highly preferred
Knowledge of current regulatory guidelines for US, Canada and Europe (strongly preferred)
Quality Systems knowledge (strongly preferred)
General level of computer proficiency – Microsoft Office, Adobe Acrobat and document management systems
Excellent interpersonal, self management and organizational skills
EUPRAXIA PHARMACEUTICALS is a clinical-stage biotechnology company leveraging proprietary and innovative delivery technology with the goal of providing the right dose of drug in the right place for the right amount of time in indications with a high unmet medical need