U S RegOps Dossier Manager

Use Your Power for Purpose

Were committed to delivering medicines to the world with greater speed, without compromising on excellence and integrity. Navigating both local and global regulations is crucial, and the dynamic regulatory landscape demands innovative thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our regulatory submissions are prepared, published, tracked, and quality-controlled to meet the highest standards. Your contributions will help us bring life-saving medicines and vaccines to patients around the world more efficiently and effectively.

What You Will Achieve

In this role, you will:

• Assist in the preparation, publication, tracking, and quality control of regulatory submissions, ensuring compliance with document management standards.
• Coordinate enterprise-wide regulatory management systems, train team members, and develop and implement strategic plans.
• Contribute to moderately complex projects, manage your own time to meet targets, and develop plans for short-term work activities.
• Execute designated operational tasks through the use of standards and tools, conforming to regulatory submission milestones and obligations.
• Support the interpretation of regulatory guidelines to produce business requirements and ensure their implementation at local and regional levels.
• Collaborate with team managers to forecast and manage project-specific resources, utilizing flexible resourcing and global load sharing as standard practice.
• Act as a Subject Matter Expert in dossier types and processes and handle curriculum and training assignments.
  
  

• BA/BS with 2+ years of experience or MBA/MS with any years of experience
• Deep understanding of the drug development process, regulatory affairs, and submission management
• Familiarity with systems and electronic technologies that support submission and planning activities
• Exceptional organizational skills and a keen attention to detail
• Ability to present scientific data effectively, both verbally and in writing
• Proficiency in English
  
  

• Masters degree
• Familiarity with pharmaceutical organizational structures, systems, and culture
• Experience in project management
• Strong analytical and problem-solving skills
• Ability to work independently and as part of a team
• Ability to manage multiple projects and priorities simultaneously
• Experience with global regulatory submissions and requirements