Reg Affairs Spec

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

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