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Job Description

About the role:

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic hematologic and other complex diseases.

The Regulatory Compliance Senior Manager ensures that the organization gains regulatory approval for new products and product amendments and maintains the currency of product licenses and permits. This role involves monitoring regulatory developments ensuring compliance and preparing necessary documentation to support Takedas mission.

How you will contribute:

• As a Regulatory Compliance Senior Manager in our PDT organization you will ensure the organization is aware of and compliant with legislation and regulations pertaining to the business

• Monitor and interpret regulatory developments determining the impact on business operations and compliance programs

• Implement compliance measures and ensure adherence to regulatory standards

• Prepare review and approve regulatory compliance documents for internal and external audiences

• Manage large projects or processes with limited oversight from the manager

• Coach review and delegate work to lower-level professionals

• Serve as a consultant to management and an external spokesperson on major matters

Minimum Requirements/Qualifications:

• BSc degree preferred; BA accepted.

• Advanced scientific degree (MSc PhD or PharmD) preferred.

• 6 years of pharmaceutical industry experience. This is inclusive of 4 years of regulatory compliance or combination of 4 years regulatory and/or related experience.

• Proficient in regulatory compliance capable of advising others and handling highly complex compliance issues independently.

• Performs advanced Environment Health and Safety tasks independently capable of coaching others and making improvement recommendations.

• Leads new product development projects advising on market analysis and customer needs capable of managing complex situations and guiding others.

• Capable of independently managing and improving organizational structures and processes can coach others in effective organization.

• Leads project management efforts in complex situations advising and coaching others and contributing to process improvements.

• Advanced writing ability capable of crafting well-structured content for a variety of complex scenarios and can mentor others in improving their writing skills.

• Fully capable of executing complex risk analysis independently advising on mitigation strategies and coaching others in risk analysis methods and principles.

• Fully capable of managing time in highly complex situations and can coach others on time management techniques and improvements.

• Excellently manages tasks requiring high attention to detail independently addresses complex scenarios and advises others on maintaining precision.

• Skilled in creating and delivering persuasive and impactful presentations in a variety of complex situations able to mentor others in developing their presentation skills.

• Advanced in auditing capable of handling highly complex situations making improvement recommendations and coaching others.

• As an expert professional within the organization you develop innovative solutions to complex problems aligned with organizational objectives. Your work involves addressing intricate issues requiring in-depth analysis and judgment. You also engage with key contacts outside your expertise area and contribute to the development of new concepts and standards. Operating with considerable autonomy you serve as a consultant to management and an external spokesperson on major matters often working independently and leading function teams or projects. Additionally you play a role in training and mentoring junior staff.

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 following Takedas Hybrid and Remote Work policy.

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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:

U.S. Base Salary Range:

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 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.

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Job Exempt