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Senior Manager, Regulatory Operations
1 month ago
Takeda Pharmaceuticals - Senior Manager, Regulatory Operations - Charleston, West Virginia 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 updated metadata in MEDIVA. You will report to the Director, Regulatory Operations, Labeling & Compliance. How you will contribute: Manage all Regulatory Operations activities involving planning, tracking, compilation, publishing, distribution, and archiving of health authority submissions. Collaborate with the external publishing vendor to publish and dispatch health authority submissions. Maintain all Regulatory-related databases in an RIM system. Independently manage assigned projects by defining submission outlines, content, format, and quality requirements for electronic submissions. Ensure accurate and timely management of tracking, compiling, publishing, quality checking, dispatching, and archiving of Health Authority submissions. Coordinate and consult with other departments on the content, review, and assembly of regulatory documentation. Assist in creating regulatory project plans and timelines for multiple projects for developmental programs. Represent Regulatory Operations on project teams for assigned projects. Archive all incoming and outgoing communications with Health Authorities. Create and maintain the regulatory information in the RIM system for assigned projects. Participate in developing, refining, and implementing internal processes, procedures, work instructions, and training programs. Support RIM system upgrades, including executing UAT for system releases. 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. Able to manage both time and priorities simultaneously. Detail-oriented self-starter with excellent organizational, planning, and follow-up skills. Strong working knowledge of regulatory submission publishing standards and procedures. Thorough understanding of FDA and other health agency regulations. Experience with document management and Regulatory Information Management (RIM). Travel up to 10%. More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that inspires and empowers you to grow through life-changing work. EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws. #J-18808-Ljbffr
