By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

About the role:

As a Senior Manager, Regulatory Operations you will work within the Vaccine Business Unit (VBU) to further the vision of Regulatory Operations by supporting HA submissions, registrations and archival, Veeva RIM processes, and maintaining an updated metadata in MEDIVA. You will report to the Director, Regulatory Operations, Labeling & Compliance.

How you will contribute:

• The Senior Manager of Regulatory Operations is responsible for managing all Regulatory Operations activities involving the planning, tracking, compilation, publishing, distribution, and archiving of health authority submissions.

• The Senior Manager will collaborate with the external publishing vendor to publish and dispatch health authority submissions.

• The Senior Manager needs to maintain all Regulatory-related databases in an RIM system.

• Independently manages assigned projects by defining submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed.

• Ensures the accurate and timely management of the tracking, compiling, publishing, quality checking, dispatching, and archiving of Health Authority submissions.

• Coordinates and consults with other departments on the content, review, and assembly of regulatory documentation. Ensures consistency, completeness, and adherence to standards for all regulatory submissions.

• Assists in creating regulatory project plans and timelines for multiple projects for developmental programs. Maintains project timelines and provides updates to senior management.

• Represents Regulatory Operations on project teams for assigned projects to support any discussion on electronic (and paper) submissions.

• Responsible for archiving all incoming and outgoing communications with Health Authorities. Utilizes the functionality in the RIM system to maintain the chronology log.

• Responsible for creating and maintaining the regulatory information in the RIM system for assigned projects. Ensures all data is updated promptly and accurately.

• Participates in developing, refining, and implementing internal processes, procedures, work instructions, and training programs for submission production and operational support activities. As needed, trains colleagues and project teams.

• Supports RIM system upgrades, including executing UAT for system releases; reviews and updates SOPs or Job Aids to reflect the new changes.

Minimum Requirements/Qualifications:

• Bachelor’s degree in a related discipline.

• Minimum 8 years of relevant experience in the biotech or pharmaceutical industry.

• Experience working independently and within a global multi-cultural framework; must be able to deliver results in a matrix organization. Efficiently/actively manage conflict seeking effective solutions for all parties. 

• Able to manage both time and priorities simultaneously; ability to assist Supervisor with day-to-day activities for projects as needed.

• Requires a detail-oriented self-starter with excellent organizational, planning, and follow-up skills, as well as communication, teamwork, and interpersonal skills.

• Ability to meet tight competing deadlines, juggle multiple priorities and multi-task.

• Strong working knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic d