Senior Manager, Regulatory Operations

at Takeda Pharmaceuticals in Springfield, Illinois, United States

Job Description

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Job Description

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 an updated metadata in MEDIVA. You will report to the Director, Regulatory Operations, Labeling & Compliance.

How you will contribute:

+ The Senior Manager of Regulatory Operations is responsible for managing all Regulatory Operations activities involving the planning, tracking, compilation, publishing, distribution, and archiving of health authority submissions.

+ The Senior Manager will collaborate with the external publishing vendor to publish and dispatch health authority submissions.

+ The Senior Manager needs to maintain all Regulatory-related databases in an RIM system.

+ Independently manages assigned projects by defining submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed.

+ Ensures the accurate and timely management of the tracking, compiling, publishing, quality checking, dispatching, and archiving of Health Authority submissions.

+ Coordinates and consults with other departments on the content, review, and assembly of regulatory documentation. Ensures consistency, completeness, and adherence to standards for all regulatory submissions.

+ Assists in creating regulatory project plans and timelines for multiple projects for developmental programs. Maintains project timelines and provides updates to senior management.

+ Represents Regulatory Operations on project teams for assigned projects to support any discussion on electronic (and paper) submissions.

+ Responsible for archiving all incoming and outgoing communications with Health Authorities. Utilizes the functionality in the RIM system to maintain the chronology log.

+ Responsible for creating and maintaining the regulatory information in the RIM system for assigned projects. Ensures all data is updated promptly and accurately.

+ Participates in developing, refining, and implementing internal processes, procedures, work instructions, and training programs for submission production and operational support activities. As needed, trains colleagues and project teams.

+ Supports RIM system upgrades, including executing UAT for system releases; reviews and updates SOPs or Job Aids to reflect the new changes.

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; must be able to deliver results in a matrix organization. Efficiently/actively manage conflict seeking effective solutions for all parties.

+ Able to manage both time and priorities simultaneously; ability to assist Supervisor with day-to-day activities for projects as needed.

+ Requires a detail-oriented self-starter with excellent organizational, planning, and follow-up skills, as well as communication, teamwork, and interpersonal skills.

+ Ability to meet tight competing deadlines, juggle multiple priorities and multi-task.

+ Strong working knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software.

+ Thorough understanding of FDA and other health agency regulations and guidance’s governing submission content and format.

+ 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 will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Massachusetts – Virtual

U.S. Base Salary Range:

$133,000.00 – $209,000.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.?The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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, and any other characteristic protected by law.

Locations

Massachusetts – Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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