Regulatory Affairs Manager

  • Regulatory Affairs Manager

    Regulatory Affairs Manager
    Our client is an international organization in the laboratory testing industry. They have asked Bryan Forrest of Lock Search Group to assist them in their search for a Regulatory Affairs Manager to join their team in North York.
    Our client is looking for a Regulatory Affairs Manager with excellent research, writing, and communication skills to work on NDS, OTC Drug & NHP Submissions. This is a senior role in a fast-paced environment where punctuality and professionalism are essential. 

    Key Responsibilities:
    • NDS and OTC Drug Submissions in Canada and the USA
    • NHP, Medical Device Submissions and Cosmetic Notifications
    • Label reviews for Drugs, NHPs, Medical Devices, Consumer Products/ Cosmetics, and Food
    • Cannabis applications and regulatory support
    • Preparation of PSUR & PBRER reports
    Qualifications:
    • Bachelor’s degree or advanced diploma in a life science (Biology, Chemistry, Microbiology, etc.)
    • Knowledgeable of Health Canada and FDA policies and guidelines to ensure regulatory approval of new drug submissions
    • Compile, complete & execute high quality regulatory drug submissions NDS/ANDS/SANDS/SNDS and monographed as per eCTD for Health Canada & FDA
    • Prepare required documentation to support product and site/establishment licence applications (labels, efficacy & safety report, finished product specifications, quality summary report as required for NHPs, and medical devices
    • Preparation of the Application to become a Licenced Producer/Grower under the Cannabis Act and Regulations and Quality Assurance System (including Quality Assurance Pre-licensing Report and Standard Operating procedures) to fulfill regulatory requirements for cannabis
    • Liaise and negotiate with regulatory authorities to ensure scientific information is being disseminated as appropriate
    • Assess international drug products dossiers, identify gaps to meet local requirements and prepare gap analysis 
    • Evaluate and file lifecycle management submissions (Notifiable Changes, Amendments and Annual Notifications of chemistry, manufacturing, and labelling updates)
    • Compile Module 3 Quality & manufacturing documents to ensure successful approval - QOS and CPID 
    • Coordination and efficient communication with client and Health Canada or FDA to process Clarification Requests for Regulatory Drug Submissions
    • Prepare registration documents for the Provincial Formularies, Federal and Territorial drug plans, and Third Party payer plans according to their respective guidelines
    • Ability to search with comfort Pub Med and other on-line databases and summarize literature
    • Proficient and comfortable working with electronic systems and with eCTD format, Word, Excel, PowerPoint
    • An excellent ability to write clearly and concisely
    • The ability to interact with staff, clients and regulatory officials in a positive and professional manner
    • A high degree of organization and attention to detail
    • Excellent time management skills
    • A team-oriented outlook with the capacity to work independently
    To apply, please submit a copy of your resume in confidence to Bryan Forrest via the “apply now” button.