Reporting to the Director, Federal Regulatory Affairs, the Regulatory Affairs (RA) Associate Manager is responsible for maintaining, updating, coordinating all federal dossiers as well as, informing and assessing new changes in the Canadian regulatory policies and guidelines.
The RA Associate Manager’s main responsibilities include establishing and maintaining an excellent working relationship with the Head office Regulatory team dedicated to Canada. The RA Associate Manager will provide input into the development of submissions for one or more products and participate in the planning and preparation of submissions or responses to Health Product Food Branch (HPFB) questions. Other responsibilities include; maintaining updates on all assigned dossiers, establishing and maintaining an excellent working relationship with HPFB staff and managing the Regulatory filing/archiving system. In addition, the candidate will be responsible for staying abreast of current HPFB regulatory policies and guidelines, assessing impact on our business and communicating potential impact to our Regulatory team. The RA Associate Manager will participate in reviewing promotional materials and assisting in Quality Control related issues. RA Associate Affairs Manager’s role will be to answer the Rx&D Code queries and serves as point of reference for questions arising internally regarding the Code. Also, ensure Rx&D Code presentation to employees and provides appropriate training of the Rx&D Code of Conduct to new employees in various departments (e.g. sales, marketing, etc.). The RA Associate Manager’s should be able to interact with various departments including Marketing, Market Access, Sales, and Research team.
University degree in a scientific field (B. Sc., B. Pharm. or M. Sc.) preferably in pharmacology, pharmacy or chemistry. Degree in Drug development is considered as an asset
Minimum of 3 years experience in a regulatory position
Knowledge of Health Canada regulations, guidelines and policies
Understanding of the drug development and commercialization process
Working knowledge of Pharmaceutical Advertising Advisory Board (PAAB) working knowledge of Rx&D Code of Ethical Practices. Servier Canada is an active member and must comply with Rx&D Code of Ethical Practices
Able to manage multiple projects and tight deadlines
Knowledge of the electronic business environment
Excellent interpersonal and communication skills
Knowledge of chemistry and manufacturing principles is an asset
Knowledge of Quality Control is an asset
Bilingualism (English & French) is an asset