Thermo Fisher Scientific Looking for Regulatory Affairs Specialist at Alberta Full Time

Job Description

Summarized Purpose:

Provides innovative solutions including regulatory expertise and client interface to provide strategic intelligence, and guidance supporting product development from preclinical through registration and product optimization. Provides strategic, expedient and efficient preparation of client deliverables that meet current local, regional and ICH regulatory and technical requirements. Acts as liaison with internal and external clients in the provision and marketing of these services.

Essential Functions:

• Prepare detailed regulatory Clinical Trial Applications to submit to Health Canada.

• Maintain the CTA submissions to end of trial.

• Update Canada sections of RegView.

• Respond for Canada, questions received from the Regulatory Intelligence team for upcoming bid/awards.

• Review clinical labels for USA and Canada on a rotational basis.

• Interact with Health Canada for questions in regard to CTA submissions.

Knowledge, Skills and Abilities:

• Good English language (written and oral) communication skills as well as local language where applicable

• Good attention to detail and quality as well as editorial/proofreading skills

• Good interpersonal skills to work effectively in a team environment.

• Good computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies.

• Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects.

• Good negotiation skills

• Capable of working independently with direction and exercising independent judgment

• Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables

• Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management

• Basic understanding of medical terminology, statistical concepts, and guidelines

• Good analytical, investigative and problem-solving skills

• Capable of interpreting data

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.