With around 30,000 people working in approximately 70 countries we are a truly global partner for better health. Takeda is dedicated to pharmaceutical innovation and tackling diseases for which there is currently no cure. We are expanding continuously into new fields of treatment and therapy. By always putting people first, we empower employees so everyone can develop to his or her full potential. We are looking for colleagues with the right skills and experiences to support us in improving the quality of the most precious thing we know: life.

We are looking for a strong candidate for the position of Regulatory Affairs Associate. 

Manages product specific regulatory projects to optimize marketing opportunities and maintain regulatory compliance throughout the lifecycle management and licensable activities.  Acts as a key contact regarding regulatory compliance of Takeda Canada’s established products.  Assist Senior Regulatory staff in the preparation of documents and the filing of submissions.

Accountabilities

Completes quality submissions to ensure timely approvals leading to compliance with Health Canada and Takeda timelines.Responds to requests from health authorities and drafts internal documents / sections of submissions for review.Assist Senior Regulatory staff in the preparation of documents and the filing of submissions.Maintenance activities for Annual Drug Notifications (ADNs) and of approved products, including change controls, label updates, notifiable changes and level III and IV changes.Maintains current knowledge of regulations, industry activities, product information, and therapeutic areas through attending conferences and monitoring relevant websites.Ensures consistency of procedures and compliance with regulations governing Takeda’s industry by following standard operating procedures, policies, and best practices.Develops practices to ensure consistency in routine activities.Reviews regulations to define and ensure labeling compliance.Accountable for project management by maintaining the most efficient processes to provide Takeda with the desired project outcomes.Assesses Takeda corporate product information against competitive product information and assesses Takeda corporate data against regulatory requirements.Interacts with Canadian Health authorities by providing comments and soliciting advice on draft guidelines and policies related to Takeda Canada’s activities. Ensures that Takeda’s interests are raised and opportunities are optimized within the regulatory environment.Promotes the knowledge of regulatory and compliance requirements to customers / partners to ensure Takeda’s activities are adhering to standard operating procedures and regulatory policies.Identifies regulatory guidance that affects labeling and assures that Labeling development processes conform to regulatory and legal requirements. Functions as a SME for regulatory labeling requirements.Creates, manages, proofreads, edits and updates all labeling development activities for assigned products (package inserts, packaging components, etc) in alignment with internal and external stakeholders for new products introductions and for updates of current product labeling with minimal supervision to execute the final deliverable.Where applicable, may serve as a member on cross-functional teams, such as brand life-cycle teams, etc. and provides risk assessments and make recommendations.Reviews marketing/sales promotional brochures and advertisements and labels for regulatory compliance

Experience

BSc University Degree in health sciences

Asset:

Masters or Advanced DegreeBilingual English/French preferred.1-3 years work experience in Regulatory Affairs or related field

Capabilities

Knowledge of Health Canada regulations. Ability to liaise with Regulatory AgenciesUnderstanding of scientific principles and regulatory/quality systems relevant to drug development. Able to provide regulatory guidance to drug development teams, merging scientific principles and Health Canada law and regulations for new product developmentKnowledge of existing legislation to ensure Takeda Canada is in full regulatory compliance with relevant guidelinesFederal legislation, regulation, policies, guidelinesPAAB, IMC regulations, policies, guidelinesICH guidelines