Strong english written and oral communication skills
The role involves serving as a senior contact providing strategic regulatory intelligence and guidance for product development from preclinical stages through registration
Job Summary
The role involves serving as a senior contact providing strategic regulatory intelligence and guidance for product development from preclinical stages through registration.
Candidates will prepare and review regulatory submissions while acting as a liaison between internal teams, external clients, and regulatory authorities.
The position requires supporting business development activities including project budgeting and forecasting alongside managing multiple projects with changing priorities.
Matching Summary
The role involves serving as a senior contact providing strategic regulatory intelligence and guidance for product development from preclinical stages through registration.
Skills & Requirements
Must-have
5+ years regulatory affairs experience
Bachelor's degree or equivalent qualification
Strong English written and oral communication skills
Knowledge of ICH and global regulatory guidelines
Experience preparing regulatory submissions
Nice-to-have
Solid negotiation skills
Ability to work independently with judgment
Training and guidance capabilities for junior members
Budgeting and forecasting support experience
Key Requirements
5+ years relevant experience
Bachelor's degree or vocational qualification
Understanding of clinical trial authorization procedures