Associate Director, Global Regulatory Affairs, CMC Small Molecules

Job Description

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 an Associate Director, GRA CMC Small Molecules where you will oversee the development and execution of regulatory CMC development and registration strategies. You will be RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff. Demonstrate high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization.

You will also communicate and negotiate with international Health Authorities as necessary, directly and indirectly. Provide regulatory CMC expertise for new business development / due diligence activities. Proactively recognizes and contributes to enhancing business processes.

As part of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC.

How You Will Contribute

• Plan, execute and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities.
• Member of global cross-functional teams which require experienced interpretation of applicable EMA / FDA / ICH / WHO / Global regulations to ensure CMC compliance within the organization.
• Support submission team members to define CMC content (data and documentation) requirements for regulatory submissions and reviews the content for conformance with established requirements.
• Support and / or contribute to business process development and enhancement.
• Evaluate new business development opportunities or participate on due diligence teams.
• Develop and maintain constructive relations with key internal and external colleagues, e.g. cross functional colleagues within Takeda, Alliance Partners, and Health Authority representatives.
• Responsible for ensuring that 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.
• Exercise good judgement in elevating and communicating actual or potential issues to line management.
• Communicates and negotiates with international Health Authorities as necessary, directly and indirectly.
• Represent Takeda RA CMC in Health Authority meetings and leads or supports CMC preparation activities for meetings with Health Authorities on CMC related matters.
• Proven ability to liaise with Regulatory Agencies, having served as lead in successful Agency Interactions related to CMC submissions and product development meetings; international experience preferred.
• Mentor and develop staff, if required, including staff professional development and project oversight accountability.
• Evaluate change proposals for regulatory impact and filing requirements.

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 "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 : $153,600.00 - $241,340.00

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

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.