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Lead Manager, Regulatory Affairs Operations
2 months ago
Takeda Pharmaceuticals - Lead Manager, Regulatory Affairs Operations
Position Overview:
In the role of Lead Manager, Regulatory Affairs Operations, you will play a pivotal part within the Vaccine Business Unit (VBU) to enhance the vision of Regulatory Operations. Your focus will be on supporting health authority submissions, registrations, and archival processes, along with overseeing Veeva RIM operations and ensuring the maintenance of accurate metadata in MEDIVA.
Key Responsibilities:
1. Oversee all Regulatory Operations functions, including the planning, tracking, compilation, publishing, distribution, and archiving of submissions to health authorities.
2. Collaborate with external publishing partners to ensure the timely publication and dispatch of submissions.
3. Maintain comprehensive databases related to regulatory activities within a Regulatory Information Management (RIM) system.
4. Independently manage assigned projects, defining submission outlines, content, format, and quality standards for electronic submissions, while coordinating with Regulatory Affairs teams as necessary.
5. Ensure precise and timely management of tracking, compiling, publishing, quality assurance, dispatching, and archiving of submissions to health authorities.
6. Work in conjunction with various departments to review and assemble regulatory documentation, ensuring consistency, completeness, and compliance with standards.
7. Assist in the creation of regulatory project plans and timelines for multiple developmental programs, maintaining oversight of project timelines and providing updates to senior leadership.
8. Represent Regulatory Operations in project teams, facilitating discussions on both electronic and paper submissions.
9. Archive all communications with health authorities, utilizing the RIM system to maintain a chronological log.
10. Create and manage regulatory information in the RIM system for assigned projects, ensuring timely and accurate updates.
11. Participate in the development and implementation of internal processes, procedures, and training programs for submission production and operational support, providing 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 biotechnology or pharmaceutical sector.
• Proven ability to work independently and collaboratively within a global, multicultural environment; adept at resolving conflicts and finding effective solutions.
• Strong organizational, planning, and follow-up skills, with a detail-oriented approach and excellent communication abilities.
• Capacity to manage competing deadlines and multiple priorities effectively.
• In-depth knowledge of regulatory submission publishing standards and procedures, including 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%.
About Takeda:
At Takeda, we are dedicated to transforming patient care through the development of innovative specialty pharmaceuticals and exceptional patient support programs. We are a patient-centric organization that inspires and empowers our employees to grow through impactful work.
As a certified Global Top Employer, Takeda promotes stimulating careers, encourages innovation, and strives for excellence in all endeavors. We cultivate an inclusive and collaborative workplace, where our teams are united by a shared commitment to delivering Better Health and a Brighter Future to individuals worldwide.