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Lead Manager, Regulatory Affairs Operations
2 months ago
About the Position:
As a Lead Manager in Regulatory Affairs Operations, you will play a pivotal role within the Vaccine Business Unit (VBU) to advance the mission of Regulatory Operations by facilitating health authority submissions, registrations, and archival processes, alongside managing Veeva RIM workflows and ensuring the accuracy of metadata in MEDIVA.
Key Responsibilities:
- Oversee all activities related to Regulatory Operations, including the planning, tracking, compilation, publishing, distribution, and archiving of submissions to health authorities.
- Collaborate with external publishing partners to ensure timely publication and dispatch of submissions.
- Maintain comprehensive databases related to regulatory matters within a Regulatory Information Management (RIM) system.
- Independently manage designated projects by outlining submission requirements, content, format, and quality standards for electronic submissions, with input from Regulatory Affairs personnel as necessary.
- Ensure precise and timely management of tracking, compiling, publishing, quality assurance, dispatching, and archiving of submissions to health authorities.
- Coordinate with various departments to review and assemble regulatory documentation, ensuring consistency, completeness, and compliance with established standards for all submissions.
- Assist in the development of regulatory project plans and timelines for multiple developmental programs, maintaining project schedules and providing updates to senior leadership.
- Represent Regulatory Operations on project teams for assigned initiatives, supporting discussions regarding electronic and paper submissions.
- Archive all communications with health authorities, utilizing the RIM system to maintain a chronological log.
- Create and manage regulatory information within the RIM system for assigned projects, ensuring all data is updated accurately and promptly.
- Participate in the development, refinement, and implementation of internal processes, procedures, work instructions, and training programs for submission production and operational support activities.
- Provide training to colleagues and project teams as needed.
- Support upgrades to the RIM system, including executing user acceptance testing for system releases and reviewing/updating standard operating procedures or job aids to reflect new changes.
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 within a diverse global framework, delivering results in a matrixed organization.
- Strong time management and prioritization skills.
- Detail-oriented self-starter with exceptional organizational, planning, and follow-up abilities, along with strong communication, teamwork, and interpersonal skills.
- Capacity to meet tight deadlines, manage multiple priorities, and multitask effectively.
- In-depth knowledge of regulatory submission publishing standards and procedures.
- Comprehensive understanding of FDA and other health agency regulations and guidelines governing submission content and format.
- Experience with document management and Regulatory Information Management (RIM).
- 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 empowers you to grow through impactful work. Recognized as a Global Top Employer, Takeda offers dynamic career opportunities, encourages innovation, and strives for excellence in all endeavors. We promote an inclusive and collaborative workplace, united by a commitment to deliver Better Health and a Brighter Future to people worldwide.
