Job Information
ThermoFisher Scientific Reg Affairs Spec in Remote, Colombia
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
The following skills are required to be successful in this position:
preparation and assembly of global regulatory submissions
interacting with sponsors,
review and assess clinical trial regulatory documents,
review and assess scientific literature.
manages project teams and preparation
participate in launch meetings, review meetings and project team meetings.
Optional skills:
- Experience with bid defense meetings
Qualifications - External
What the role requires you to have:
Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job
Knowledge of the global clinical trials landscape
Knowledge, Skills and Abilities:
Excellent command of the English language (written and oral) as well as local language where applicable
Excellent attention to detail and quality as well as excellent editorial/proofreading skills
Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
Excllent analytical, investigative and problem-solving skills
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.