Senior Manager, Global Regulatory Labeling Strategy - Remote

Senior Manager, Global Regulatory Labeling Strategy

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Senior Manager, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of assigned product(s) in various stages of drug development, which may include products of medium complexity and updates to TLP, CCDS, USPI and EU SmPC. You will also be responsible for providing support to the development and implementation of labeling content and strategy of high complexity product(s).

How You Will Contribute :

• Management of Labeling Cross-Functional Teams
• Interface with Senior Management Cross-Functional Team (GLOC)
• Labeling Documents Authoring, Submission, and Labeling Negotiations
• Management of Local Exceptions and LOC Interactions
• Escalation Process and Stakeholder Management
• Precedent Search and Labeling Trends
• Working within Labeling Team and GRA
• Support in Managing Labeling Deliverables for Medium and / or High Complexity Products
• Vendor Management

Minimum Requirements / Qualifications :

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 "remote" in accordance with Takeda's Hybrid and Remote Work policy.

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 : $137,000.00 - $215,270.00

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

Job Exempt : Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #LI-Remote