ABOUT US

Accord Healthcare Inc. is a young and dynamic pharmaceutical company. Operating in Canada since 2009, Accord Healthcare is committed to providing high quality, cost effective generic medicines to Canadian Patients. By being vertically integrated and owning all steps of pharmaceutical development and production process, Accord brings high quality medicines to patients faster, more economically and with greater innovation than our rivals. In Canada, we have refocused our strategy on oral solid products in order to create better value while supporting the needs of our wholesaler and retail pharmacy partners. Accord Healthcare markets more than 50 oral solid and injectable generic molecules. In line with our focus on patient and medicines safety, Accord has introduced a range of Ready-to-Use IV oncology products. The world of pharmaceuticals is changing and Accord is one of the fastest growing companies in the Canadian generic sector. Watch us evolve to meet the challenges of the future. Accord Healthcare is a wholly owned subsidiary of Intas Pharmaceutical; a vertically integrated global pharmaceutical company specializing in the development and manufacturing of APIs, Generic Medicines and Biopharmaceuticals.
This is an office-based position in Montreal (Kirkland, QC). We offer a hybrid work model. We are hiring a bilingual (English and French) Regulatory Affairs Associate (Entry-Level).
The Regulatory Affairs Associate is responsible for supporting the execution of activities related to pharmacovigilance, regulatory affairs and labeling.
The Associate will focus on reviewing pharmacovigilance documents and labelling activities including product monograph preparation and review of package inserts. The Associate will ensure accuracy of both regulatory and customer requirements and will ensure compliance with Canadian regulations.

EDUCATION MINIMUM REQUIREMENTS:

• B.Sc in Science: pharmaceutical sciences, pharmacology, biochemistry, chemistry, microbiology, biotechnology or equivalent.

REQUIRED EXPERIENCE AND SKILLS:

• Ability to quickly adapt to a changing environment and handle multiple priorities while utilizing appropriate resources in accordance with timelines/deadlines and appropriate regulations.
• Willingness to learn and ability to work independently.
• Demonstrates ability to work in partnership with others (internally and externally).
• Attention to detail: High level of accuracy & quality in work.
• Excellent problem solving skills, analytical skills and critical thinking.
• Superior communication skills, oral and written bilingualism (English and French).
• Proficiency with Microsoft Office: Word, Excel, Power Point and Outlook.
• Knowledge of Canadian regulations and Guidelines, GVPs, GDPs and GMPs.

• Participate in day-to-day activities to support the Regulatory Affairs (RA) and Pharmacovigilance (PV) department according to GVPs, GDPs, GMPs and company policies and SOPs
• Preparation of Product Monographs (English and French) for new submissions and for safety updates including safety updates to be in line with Canadian Reference Products
• Preparation of Product Monographs as per the latest Health Canada template (currently, Master Template)
• Support Health Canada submissions (ANDS, NDS and SANDS) including sequence submission (eCTD) to Health Canada
• Review and approval of artworks (product labels and package inserts) according to latest Canadian regulations, GS1 standards and customer requirements
• Medical Information handling including the preparation, review and maintenance of documents to send to inquirers
• Support the preparation and tracking of submissions to provincial formularies for generic products
• Preparation of Certificate of Pharmaceutical Product Applications to Health Canada
• Handling and tracking of Access to Information Requests from Health Canada
• Data Entry into GS1 ProSync for ECCnet Registry
• Support the preparation of regulatory/pharmacovigilance documents, maintenance of tracking tools, and performs other activities as requested by the Manager of Regulatory Affairs and Pharmacovigilance or Vice President of Global Quality and Compliance.