Lead Manager, Regulatory Affairs Operations

2 weeks ago


Topeka, Kansas, United States Takeda Pharmaceuticals Full time


**Position Overview:**
As a Lead Manager in Regulatory Affairs Operations, you will play a pivotal role within the Vaccine Business Unit (VBU) at Takeda Pharmaceuticals. Your primary focus will be to enhance the vision of Regulatory Operations by facilitating health authority submissions, registrations, and archival processes, while overseeing Veeva RIM procedures and ensuring that metadata in MEDIVA is consistently updated.


**Key Responsibilities:**
- Manage all activities related to Regulatory Operations, including the planning, tracking, compilation, publishing, distribution, and archiving of submissions to health authorities.
- Collaborate with external publishing vendors to ensure the timely publication and dispatch of regulatory submissions.
- Maintain comprehensive Regulatory-related databases within a Regulatory Information Management (RIM) system.
- Independently oversee assigned projects, defining submission outlines, content, format, and quality standards for electronic submissions, with necessary input from Regulatory Affairs personnel.
- Ensure the precise and timely management of tracking, compiling, publishing, quality checking, dispatching, and archiving of submissions to health authorities.
- Coordinate with various departments to ensure the content, review, and assembly of regulatory documentation are consistent, complete, and adhere to established standards.
- Assist in developing regulatory project plans and timelines for multiple developmental programs, providing updates to senior management as required.
- Represent Regulatory Operations on project teams, contributing to discussions regarding electronic and paper submissions.
- Archive all communications with health authorities, utilizing the RIM system to maintain a chronological log.
- Create and maintain regulatory information in the RIM system for assigned projects, ensuring all data is updated accurately and promptly.


**Qualifications:**
- Bachelor’s degree in a relevant field.
- A minimum of 8 years of experience in the biotech or pharmaceutical industry.
- Proven ability to work independently and collaboratively within a global, multicultural environment, effectively managing conflicts and seeking solutions.
- Strong organizational, planning, and follow-up skills, with the ability to manage multiple priorities and deadlines simultaneously.
- In-depth knowledge of regulatory submission publishing standards and procedures, along with proficiency in electronic document management systems and regulatory publishing software.
- Comprehensive understanding of FDA and other health agency regulations governing submission content and format.
- Experience with document management and Regulatory Information Management (RIM) systems.
- 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-focused organization that empowers our employees to grow through impactful work. Recognized as a Global Top Employer, Takeda promotes stimulating careers, encourages innovation, and strives for excellence in all endeavors. We cultivate an inclusive and collaborative workplace, united by our commitment to delivering Better Health and a Brighter Future to individuals worldwide.



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