Senior Manager, Global Regulatory Affairs CMC

About The Role

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.

This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team's delivery of critical functions as follows:

• With some supervision, leads the execution of regulatory CMC investigational, registration and/or post-approval strategies for assigned products.

• RA CMC member on the Global Regulatory CMC team may act as the delegate for the GRA CMC Product Lead at Regulatory, Pharmaceutical Development, and Commercial project teams throughout clinical development and commercial lifecycle.

• Has a strong foundational understanding of global RA CMC regulations and guidelines and can apply this understanding to projects to enhance probability of regulatory success and regulatory compliance.

• Ability to draw from precedents and other regulatory intelligence beyond regulations. Strong analytical or process understanding that enables the development of robust and accurate submissions.

• Develops constructive relationships with and proactively communicates issues to key internal and external colleagues, including Alliance Partners.

How You Will Contribute

• With some supervision, plans, executes and manages regulatory submissions according to the regulatory strategy laid out by the GRA CMC Product/Device lead(s)

• Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement. Ability to understand the overall product strategy and anticipate future challenges.

• With supervision, supports CMC preparation activities for meetings with Health Authorities on CMC related matters.

• Interacts directly with international Health Authorities on administrative procedural topics, as required.

• Fosters constructive working relationships when interacting with internal and/or external colleagues.

• Evaluates change proposals for global regulatory impact with some supervision.

• As a RA CMC member, ensures and/or enhances regulatory compliance.

• Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.

Minimum Requirements/Qualifications

• BS/BA Degree in a Scientific Discipline, Advanced Degree preferred.

• 6+ years pharmaceutical Regulatory CMC or Device experience, including experience leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA. Equivalent industry experience in Pharmaceutical Development, Analytical Development, Production, Quality Assurance can be considered.

• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.

• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.

• Analyze issues with attention to detail.

• Ability to assess alternative approaches.

• Base regulatory strategy recommendations on precedents and other regulatory intelligence as well as regulations and guidelines.

• Able to deal with issues of critical importance with some supervision. Exercises good judgement in elevating and communicating actual or potential issues to line management.

• Understands who is responsible for different decisions and escalates as necessary

• Applies decisions taken by the company

• Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.

• Intentionally promotes an inclusive culture

• Applies the given prioritization framework with limited support

• Excellent written and oral communication skills required.

• Exercises good judgement in elevating and communicating actual or potential issues to line management.

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 Takeda's 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: Boston, MA

U.S. Base Salary Range: $137,000.00 - $215,270.00

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt 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.