Prepares and reviews regulatory submissions.
Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies.
Leads the development and implementation of project-specific processes for sponsors.
Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.
Provides training and guidance to junior team members as appropriate.
Participates in project launch meetings, review meetings and project team meetings.
Supports business development activities, including project budgeting/forecasting.

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Strong English language (written and oral) communication skills as well as local language where applicable
Strong interpersonal skills to work effectively in a team environment and act as a liaison with other departments
Solid computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
Solid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
Solid negotiation skills
Solid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines

Senior Regulatory Affairs Specialist – Global Clinical Trial Applications

Key skills