**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**OfficeThe 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 landscapeKnowledge, 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 newtechnologies- 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 ICHand other global regulatory guidelines- Excllent analytical, investigative and problem-solving skills