The Premier Resource for All Your Professional Needs

We are looking for a Specialist, Regulatory Affairs to join our team. The Specialist, Regulatory Affairs is responsible for managing the CTA acceptability with Health Canada's TPD, NNHPD, MDD and BRDD. The position provides regulatory support to the other company divisions and acts as a regulatory consultant with the clients who drug development strategy is to gain drug approval primarily by Health Canada and as required to other international authorities.

Main Responsibilities:

• Prepare, review and submit CTAs for small molecules, biologics and natural health products to Health Canada's Directorates (TPD, BRDD, NNHPD); and to the Office of Controlled Substances (OCS);
• Facilitate communication and exchange between stakeholders and Health Canada and other agencies as needed;
• Provide strategic guidance on regulatory requirements to sponsors;
• Maintenance of submission (CTA-A, notification, cancellation);
• May participates to drug development files to be submitted to the regulatory bodies (ex.: pre-IND, IND, pre-CTA);
• Maintain current awareness on regulatory guidelines (such as Health Canada's TPD, NNHPD, and BRDD, FDA) and ensure processes are adjusted as necessary;
• Provide in-house training courses to new and existing employees as required;
• Represents Altasciences in scientific meetings/exhibitions or business meetings;
• Contributes to product regulatory assessments;
• Contribute to regulatory intelligence and feasibility initiatives;
• Facilitate the management of regulatory information requests for their prompt resolution and identification of improvement opportunities.

• Bachelor's degree in Life Sciences (certification/training in regulatory affairs is an asset);
• Three (3) to five (5) years’ related experience, in the regulatory field preferred;
• Strong interpersonal skills;
• Good verbal and written communication skills (English);
• Ability to work with a multi-disciplinary team of professionals;
• Leadership role on a Regulatory Affairs or Compliance Initiative;
• Good knowledge of Health Canada  and FDA standards and guidelines;
• Knowledge of CMC, pharmaceutical manufacturing and analytical chemistry (asset);
• Experience of filing and managing regulatory submissions, including electronic submission in eCTD formats (asset).
• Understanding of clinical research, drug development process, and applicable regulatory guidelines;
• Good computer skills (Microsoft Word, Excel, and Power Point);
• Remote position (based in Canada or in United States).