Senior Manager, Regulatory Operations

Job summary

The role involves overseeing regulatory publishing and submission management activities for global electronic submissions to various health authorities. The Senior Manager will contribute to innovation in regulatory processes and support the implementation of new technology solutions.

Qualifications

• BA/BS degree or equivalent
• Minimum of 8 years of experience in the pharmaceutical industry, specifically in Regulatory Operations

Responsibilities

• Create, assemble, and publish major and routine global electronic submissions (eCTD and NeeS) including MAA, BLAs, and INDs.
• Act as the global submissions expert, guiding teams on e-submission standards and lifecycle management.
• Perform quality control and technical validation of electronic submissions to ensure compliance.
• Ensure adherence to submission timelines and health authority specifications.
• Collaborate with functional areas to ensure document compliance with authoring style guides.
• Maintain knowledge of regulations governing controlled documents required by health authorities.
• Represent Regulatory Operations on project teams, managing timelines and deliverables.

Skills

• Knowledge of IND, BLA, MAA, and CTD requirements and guidelines.
• Familiarity with electronic publishing systems and software.
• Proficiency in MS Office Suite and Adobe Acrobat.
• Strong communication skills, both oral and written.
• Ability to manage multiple tasks and work independently or in teams.

Education

• BA/BS degree or equivalent.

Tools

• Electronic Document Management Systems.