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Lead Manager, Regulatory Affairs Operations

2 months ago

Austin, Texas, United States Takeda Pharmaceuticals Full time


Takeda Pharmaceuticals - Lead Manager, Regulatory Affairs Operations

Position Overview:
As a Lead Manager in Regulatory Affairs Operations, you will be integral to the Vaccine Business Unit (VBU), driving the vision of Regulatory Operations through the management of health authority submissions, registrations, and archival processes. You will collaborate closely with the Director of Regulatory Operations, Labeling & Compliance.

Key Responsibilities:
1. Oversee all activities related to Regulatory Operations, including planning, tracking, compiling, publishing, distributing, and archiving submissions to health authorities.
2. Partner with external publishing vendors to ensure the timely publication and dispatch of submissions.
3. Maintain comprehensive databases related to regulatory affairs within a Regulatory Information Management (RIM) system.
4. Independently manage assigned projects, defining outlines, content, format, and quality requirements for electronic submissions, while engaging with Regulatory Affairs staff as necessary.

5. Ensure the precise and timely execution of tracking, compiling, publishing, quality assurance, dispatching, and archiving of submissions to health authorities.
6. Collaborate with various departments to review and assemble regulatory documentation, ensuring consistency and adherence to standards.

7. Assist in the development of regulatory project plans and timelines for multiple projects, providing updates to senior management as needed.
8. Represent Regulatory Operations on project teams, facilitating discussions regarding electronic and paper submissions.

9. Archive all communications with health authorities, utilizing the RIM system to maintain a chronological log.
10. Create and maintain regulatory information in the RIM system for assigned projects, ensuring data accuracy and timeliness.

11. Participate in the development and implementation of internal processes, procedures, and training programs for submission production and operational support activities; provide training to colleagues and project teams as required.

12. Support upgrades to the RIM system, including executing user acceptance testing for system releases and updating standard operating procedures or job aids accordingly.

Qualifications:
- Bachelor’s degree in a relevant field.
- At least 8 years of pertinent experience in the biotech or pharmaceutical sector.
- Proven ability to work independently and collaboratively within a global, multicultural environment, delivering results in a matrix organization.
- Strong organizational skills with the ability to manage multiple priorities and deadlines effectively.

- Detail-oriented self-starter with excellent communication, teamwork, and interpersonal skills.
- In-depth knowledge of regulatory submission publishing standards and procedures, along with experience in document management and Regulatory Information Management (RIM).

- Familiarity with FDA and other health agency regulations governing submission content and format.
- Willingness to travel up to 10% as required.

About Takeda:
At Takeda, we are dedicated to transforming patient care through innovative specialty pharmaceuticals and exceptional patient support programs. We are a patient-centric organization that encourages personal and professional growth through impactful work.

Recognized as a Global Top Employer, Takeda fosters stimulating careers, promotes innovation, and strives for excellence in all endeavors. We are committed to creating an inclusive and collaborative workplace, united by our mission to deliver Better Health and a Brighter Future globally.