Your role will be essential in ensuring that our regulatory submissions are prepared, published, tracked, and quality-controlled to meet the highest standards, ultimately supporting patients globally
Job Summary
Your role will be essential in ensuring that our regulatory submissions are prepared, published, tracked, and quality-controlled to meet the highest standards, ultimately supporting patients globally.
Assist in the preparation, publication, tracking, and quality control of regulatory submissions, ensuring compliance with document management standards.
Help interpret regulatory guidelines to produce business requirements and ensure their implementation at the local level, promoting quality as a best practice.
Matching Summary
Your role will be essential in ensuring that our regulatory submissions are prepared, published, tracked, and quality-controlled to meet the highest standards, ultimately supporting patients globally.
Skills & Requirements
Must-have
electronic submissions build
regulated environment coordination
drug development process knowledge
submission and planning systems
Nice-to-have
managing timelines and resources
leading projects from inception
risk management and problem-solving
attention to detail and analytical skills
Key Requirements
Bachelor's degree or Associate's degree with 2 years experience or High School diploma with 6 years experience
Demonstrated experience in electronic submissions build
Proven coordination of activities in a highly regulated environment
Experience working in a challenging customer service setting
Knowledge of the drug development process
In-depth understanding of systems and electronic technologies