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Lead Manager, Regulatory Affairs Operations

2 months ago

Charleston, West Virginia, United States Takeda Pharmaceuticals Full time

Company Overview:
At Takeda Pharmaceuticals, we are dedicated to transforming patient care through innovative specialty pharmaceuticals and exceptional patient support initiatives.

Position Summary:
As a Lead Manager in Regulatory Affairs Operations, you will play a crucial role within the Vaccine Business Unit (VBU) to advance the mission of Regulatory Operations. Your responsibilities will encompass supporting health authority submissions, registrations, and archival processes, alongside managing Veeva RIM operations and ensuring accurate metadata in MEDIVA.

Key Responsibilities:
- Oversee all activities related to Regulatory Operations, including planning, tracking, compilation, publishing, distribution, and archiving of submissions to health authorities.
- Collaborate effectively with external publishing partners to ensure timely dispatch of submissions.
- Maintain comprehensive databases related to regulatory affairs within a Regulatory Information Management (RIM) system.
- Independently manage projects by establishing submission outlines, content specifications, format, and quality standards for electronic submissions.
- Ensure precise and timely execution of tracking, compiling, publishing, quality assurance, dispatching, and archiving of submissions.
- Coordinate with various departments to review and assemble regulatory documentation.
- Assist in developing regulatory project plans and timelines for multiple developmental programs.
- Represent Regulatory Operations in project teams for assigned initiatives.
- Archive all communications with health authorities, both incoming and outgoing.
- Create and sustain regulatory information within the RIM system for assigned projects.
- Participate in the enhancement and implementation of internal processes, procedures, and training programs.
- Support upgrades to the RIM system, including executing user acceptance testing for system releases.

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 environment.
- Strong time management and prioritization skills.
- Detail-oriented self-starter with exceptional organizational, planning, and follow-up capabilities.
- In-depth knowledge of regulatory submission publishing standards and practices.
- Comprehensive understanding of FDA and other health agency regulations.
- Experience with document management and Regulatory Information Management (RIM).
- Willingness to travel up to 10%.

Diversity and Inclusion:
Takeda is committed to fostering a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or veteran status, in accordance with applicable laws.