Management supports end-to-end regulatory activities for assigned projects, including executing the preparation and compilation of compliant US IND and marketing maintenance submissions for global health authorities
Job Summary
Management supports end-to-end regulatory activities for assigned projects, including executing the preparation and compilation of compliant US IND and marketing maintenance submissions for global health authorities.
Collaborate with stakeholders to define eCTD submission strategies and document requirements, ensuring alignment with regulatory standards and project timelines.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
Matching Summary
Management supports end-to-end regulatory activities for assigned projects, including executing the preparation and compilation of compliant US IND and marketing maintenance submissions for global health authorities.
Salary
Base: zł116,650 - zł141,347; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Not specified
Skills & Requirements
Must-have
eCTD submission strategies
Global Submission Plan execution
eCTD publishing tool
Veeva RIM systems
regulatory requirements maintenance
Nice-to-have
innovation and process simplification
artificial intelligence and automation tools
balance and flexibility
high-achieving teams
Key Requirements
BA/BS degree, science/technology field preferred
1+ years relevant submissions experience
Foundational knowledge of global regulatory practices
Strong critical thinking and problem-solving skills
Effective stakeholder engagement and communication
Proficiency in English (written and oral)
Ability to execute and prioritize non-complex projects
Basic presentation skills
Proficiency with desktop software and regulatory systems