This position is instrumental to the organization and provides complete Regulatory Affairs and ISO support to both internal departments, as well as directly to our customers. Main liaison with external partners such as auditors, inspectors, consultants, etc. on matters relating to Regulatory, ISO and QMS.
Obtain and evaluate technical documentation relative to regulatory requirements.
On-going review of product compliance relative to the changing regulations
Implement appropriate strategies and changes necessary to meet evolving regulatory initiatives
Plans and executes the preparation of regulatory submissions, amendments, and annual reports for all authorities and governing bodies
Including, providing assistance with annual product quality reviews (APQR) and adverse drug reporting (ADR) specifically in the area of literature search in support of annual summary reports.
For markets outside Canada, (as required), works with regulatory contacts and consultants to facilitate preparation of their marketing application, post approval submission documents
Monitors the progress of agency review of regulatory submissions and follows up with applicable parties
Coordinates, prepares, and submits response to Health Authority questions
Follows up with regulatory contact on their progress with the foreign agency
Responsible to promote awareness of ISO standards and requirements throughout the organization
Provides regulatory advice/support to internal departments such as R&D, QA, and product development
Assist in the review of all technical documentation for product release; develop procedures and maintain files in compliance with Canadian GMP’s
Lead support to all Health Authority inspections such as Health Canada and FDA audits
Lead support for all ISO audits
Registering of products including DIN’s, NHP’s, Medical Devices, etc.
Responsible for the renewal and maintenance of all licenses including DEL, MDE, NHP, etc.
Reviews and prepares ingredient lists as requested
Review and prepares SDS and MSDS’s as requested
Other duties as assigned
Skills & Qualifications:
Proficient in Microsoft office, including: outlook, word, excel, power point, TEAMS, etc.
Excellent organizational, time management, written and verbal communication skills
Demonstrated ability to work well under pressure, while managing conflicting priorities and tight deadlines
Ability to work professionally and collaboratively with all internal departments and external customers
Self-starter who is analytically minded, adept problem solver and able to work independently and efficiently
In-depth understanding of global regulatory requirements for cosmetics, DIN’s, NHP’s and Medical Devices