Medical Jurisprudence jobs

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