Regulatory Affairs Specialist

The Regulatory Affairs Specialist has responsibility for providing comprehensive regulatory services to clients within the pharmaceutical, biologic, medical device or other regulatory service environment. This will include support for assessment, registration, maintenance and other activities as assigned. The primarily responsibilities of this job include:

• Supports Manager/Directors/project teams in the preparation of all submission types in adherence with applicable legislation, regulations and guidelines facilitating approvals and continued client compliance.

• Maintains a positive and productive liaison with internal and external contacts. This may include clients, regulatory agencies, and related institutions.

• Attends formal interactions (face-to-face meetings, teleconferences etc) with clients, and possibly, government agencies. Builds positive working relationships with clients.

• Assists in the development of assessments and strategic regulatory plans for client product development programs

• Supports the development of initial or alternative strategies, consulting with their manager or other resources within the organization. Assist in identification of project issues.

• Responsible for supporting project workflow, including prioritizing project objectives for smaller projects and portions of larger projects, and establishing timeframes for projects with guidance from Manager/Director/senior team members.

• Responsible for overseeing progress and completion of their own projects and sub-projects ensuring timeframes and deadlines are met

• Supports submission approvals through effective communication with project team and client.

• Reviews applicable client source documents to ensure they are consistent and editorially correct

Required experience:

• Minimum of BS in Life Science, healthcare, engineering preferred

• Post-graduate certificate in regulatory affairs preferred

• Minimum of 2 years of relevant experience

• Health Canada submission experience preferred

• Understanding of local Health Authority regulations, guidelines, policies

• Ability to maintain a high level of accuracy and attention to detail

• Effective project management skills