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Job Description

About the role:

• With minimal supervision develops and 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 serve as or 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 and deep foundational understanding of global RA CMC regulations and guidelines. Can apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance. Ability to draw from prior experience precedents and other regulatory intelligence beyond 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.

• Successfully communicates and negotiates with Health Authorities directly and indirectly.

• Able to apply GRA CMC knowledge to address and overcome challenges that arise during development and commercialization.

How you will contribute:

• With minimal supervision develops plans executes and manages regulatory submissions per the GRA CMC Product Team technical regulatory strategy

• Independently defines CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.

• With supervision may represent Takeda RA CMC in Health Authority meetings and support 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.

• As a GRA CMC member ensures regulatory compliance with HA conformance with Takeda controlled procedures and GRA CMC best practices.

• 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.

• Reviews provides regulatory CMC input and approves as needed technical protocols reports etc. to ensure alignment with global regulatory requirements and standards.

• When in a GRA CMC Product Team lead role prepares and maintains relevant regulatory documentation (e.g. technical regulatory strategy documents storyboards risk assessments etc.) and provides tactical regulatory guidance to product teams in line with global regulatory for development and / or commercial products approvals and meeting targets for projects/products within respective modalities.

• Supports and/ or leads assigned global regulatory submissions (e.g. Core Dossiers INDs CTAs BLAs MAAs Variations etc.) through product lifecycle.

• Works effectively across a complex matrix environment with stakeholders to ensure effective strategies are implemented and project execution is on target.

• Proactively communicates CMC regulatory strategies key issues and risks through assigned programs / products development activities and LCM in adequate and timely manner to cross-functional programs/ products teams and management level within GRA CMC GRA PS GMS and QA - as appropriate.

Minimum Requirements/Qualifications:

• BS/BA Degree in a Scientific Discipline Advanced Degree (M.S. Ph.D. etc.) preferred.

• 10 years of overall biopharmaceutical/device industry experience with 5 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.

• 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 minimal 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 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