The Regulatory Affairs Associate works in a cross-functional project environment to support assessment of products against regulatory frameworks and registration of products in North America.
Primary Responsibilities
· Compiles regulatory applications (primarily for Health Canada and the FDA) to achieve departmental and organizational objectives.
· Prepares regulatory documentation as appropriate in accordance with product classification and associated regulatory pathways (e.g., OTC/Pharmaceutical Drugs, Food Ingredients, Natural Health Products (NHPs)/Dietary Supplements, Veterinary Health Products, Cosmetics, Medical Devices).
· Supports literature reviews and drafting of safety and efficacy data.
· Supports reviews of product and manufacturing changes for compliance with applicable regulations.
· Keeps abreast of domestic and global regulatory trends, laws, and movements
Core Competencies
· Proficient knowledge of new product and process development, current regulatory issues and regulations in Canada and the U.S. for NHPs/dietary supplements, prescription and non-prescription drugs, biologics, and medical devices preferred;
· Excellent oral and written communication, including technical writing skills and the ability to review and critique regulatory documents
· Ability to work well within a team and as an individual contributor.
· Computer literacy with MS Office Suite
Qualifications
· Bachelor’s Degree in a scientific discipline
· Minimum of 1-2 years industry experience, within the regulatory affairs function of a CRO/CPG/Pharmaceutical/Nutraceutical/Medical Device company
Pay: $46,563.40-$60,000.00 per year
Work Location: In person
