Reg Affairs Spec

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.

• Experience with bid defense meetings

• 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

Want more jobs like this?

Get jobs that are Remote delivered to your inbox every week.

Get Jobs

Send me The Muse newsletters for the best in career advice and job search tips.

By signing up, you agree to our Terms of Service & Privacy Policy.

• 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