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Job Description

OBJECTIVES/PURPOSE

• Prepare, submit, track, and maintain new and existing facility license/registration applications to relevant authorities.
• Prepare and submit additional regulatory submissions or reports.
• Serve as direct liaison with relevant health authorities under the supervision of direct manager.
• Represent regulatory on relevant project teams.

SCOPE

Responsible for the submission and maintenance of regulatory compliance for BioLife facilities (collection centers, laboratories, and warehouses) including regulatory reporting, submissions, and licenses/certificates.

ACCOUNTABILITIES

Facility Support (50%)

• Prepare and submit new facility license/registration applications to relevant authorities in the US (e.g., FDA, CLIA, State DOH, PPTA, etc).
• Track license/registration renewals. Submit renewals timely to ensure continuity in maintaining current.
• Prepare and submit other regulatory submissions, applications, reports, and notifications in a timely manner according to regulatory and company requirements.

Document Control / Administration (20%)

• Review, evaluate, and communicate new and revised regulations.
• Respond to regulatory agency (include BPD reports), field locations and corporate department requests when required.

Administrative Support (15%)

• Develop and manage regulatory project plans.
• Maintain department metrics.
• Prepare, review, and approve procedures as required.

Collaborative Support (15%)

• Represent Regulatory Affairs in project teams; provide regulatory advice.
• Provide support, guidance, and coaching to other Regulatory Affairs team members.
• Provide classroom and virtual training on Regulatory topics as required.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Working knowledge of applicable US federal, state, and local laws and how those laws impact the facilities that are being supported.

Leadership

• Accountable and results oriented.
• Ability to identify potential challenges and opportunities and make recommendations.
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company.
• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization.

Decision-making and Autonomy

• Accountable for acting decisively and exercise sound judgment in making decisions.
• Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution. Interaction
• Customer focus – willing to help, respectful, prompt, and accountable.
• Strong communication skills (written and oral).
• Team member with other departments/functions as needed.

Innovation

• Working knowledge of applicable US federal, state, and local laws and how those laws impact the facilities that are being supported.
• Ability to identify compliance risk and escalate when necessary.

Complexity

• Disciplined action and execution, ability to drive operational excellence, promote teamwork, and communicate effectively.
• Ability to provide data that will resolve or simplifies complexity between functional groups.

EDUCATION AND EXPERIENCE REQUIREMENTS

• Bachelor’s degree required. Prior experience in the plasma, plasma-derived therapies or biologics industry preferred.

WHAT TAKEDA CAN OFFER YOU:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs and company match of charitable contributions
• Family Planning Support
• Flexible Ways of Working
• Tuition Reimbursement

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.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

#Li-Hybrid

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.

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