Global Regulatory Affairs CMC Global Product Lead

Takeda Pharmaceutical Company Limited; Boston (MA); Hybrid; USD 174,000 - 275,000; Full time

Job summary

Takeda is seeking a Director of CMC Regulatory Affairs to oversee regulatory submissions and ensure compliance with global regulations. This critical role requires leadership in managing regulatory strategies, negotiating with health authorities, and contributing to transformative therapies that improve patient care. A strong background in drug development and regulatory affairs is essential for success in this position.

Benefits

Medical, dental, and vision insurance

401(k) plan with company match

Tuition reimbursement program

Paid volunteer time off

Paid vacation up to 120 hours per year

Qualifications

• Comprehensive knowledge of drug development and CMC regulatory requirements.
• Proficient in negotiations with health authorities to secure regulatory approvals.
• Skilled in managing multiple projects and leading teams.

Responsibilities

• Manage regulatory submissions for clinical development and marketing applications.
• Ensure compliance with EMA/FDA/ICH/WHO regulations.
• Lead teams in establishing regulatory submission content and strategies.

Skills

Negotiation with health authorities

Regulatory compliance assessment

Leadership in cross-functional teams

Project management

Excellent communication

Education

Relevant degree in pharmaceutical sciences or related field

Job description

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

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.
The Director CMC Regulatory Affairs is responsible for ensuring regulatory approval for new products and product amendments, as well as maintaining the currency of product licenses and permits. This role helps ensure compliance with legislation and regulations, contributing to Takeda's mission of delivering transformative therapies to patients.

How you will contribute:

• Manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities
• Participate in global teams to ensure CMC compliance with applicable EMA/FDA/ICH/WHO/Global regulations
• Evaluate change proposals for regulatory impact and filing requirements
• Lead team members in establishing CMC content requirements for regulatory submissions and review this content for conformance with established requirements
• Lead and contribute to business process development
• Maintain constructive relations with essential colleagues, including Alliance Partners and Health Authority representatives
• Successfully communicate and negotiate with international Health Authorities, representing Takeda Global Regulatory Affairs CMC in meetings
• Provide strategic direction and oversight to managers across various functional areas, ensuring successful execution of major initiatives.

Minimum Requirements/Qualifications:

• Applies comprehensive knowledge of drug development and CMC regulatory requirements in strategic planning and execution.
• Expert in navigating negotiations with health authorities, ensuring favorable outcomes for regulatory submissions.
• Proficient in assessing regulatory compliance and implementing necessary changes to adhere to new regulations.
• Skilled in leading and developing teams, providing direction and support in complex regulatory matters.
• Demonstrates strong leadership in cross-functional collaborations, driving regulatory strategies that align with business objectives.
• Capable of managing multiple projects simultaneously, with a strong ability to prioritize and delegate effectively.
• Excellent communication skills, adept at crafting clear and persuasive communications for various stakeholders.
• As a leader of a sizable (functional) area, serving as the primary internal and external contact for contracts and operations.
• Your responsibilities include conducting high-level briefings and technical meetings, interacting with managers of equivalent status, and crafting corporate and organizational policies.
• You will provide strategic direction and oversight to managers across various functional areas, prioritizing the successful execution of major initiatives and ensuring that budgets, schedules, and performance standards are both realistically established and achieved.
• Your role focuses on strategic impact rather than day-to-day operational involvement.

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.

#LI-Hybrid

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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:
$174,500.00 - $274,230.00

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, MALexington, MA

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.