U.S. RegOps Dossier Manager
- Chennai, Tamil Nadu
- Permanent
- Full-time
- 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
- Master's 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