Provides regulatory advice and carries out projects in the provision of regulatory affairs services:
Acts as liaison with internal team members in the provision of these services.
Works with the Regulatory Affairs Management to perform the day to day operational aspects of the Department such as: assessment of regulatory documents, preparation and assembly of global regulatory submissions, QC review of the final submission package.
Collaborate with PPD project teams and Health Authorities regarding regulatory strategy/submission activities.
Develops and maintains a collaborative working relationship with Project Managers and project team members for assigned projects.
Advises and directs project team as to their responsibilities relative to regulatory strategy/submission activities.
Acts as a key liaison between Regulatory Affairs Department and project team for assigned projects.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
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Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Knowledge, Skills and Abilities:
Some regulatory affairs experience is preferable but not required
An appreciation of the requirements, timelines and processes for regulatory applications globally is a valuable asset.
Previous experience with clinical trials application compilation and submissions in EU and other countries is an advantage.
Excellent English language interpersonal skills, both verbal and in writing.
Digital literacy (Microsoft office) and experience in applications used in clinical trials (eTMF, CTMS) would be an advantage
Good organizational and planning skills. Ability for multiple project tasking
Proven track record to work optimally in a team, including in a multinational one
Problem solving skills and strong attention to detail
Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment. Occasional drives to site locations with occasional travel both domestic and international
Job ID: ThermoFisher-R-01285901_1005 Employment Type: Full Time
