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 Takedas 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.

As Executive Director Global Regulatory Affairs CMC Early Development you will provide strategic leadership and development to global CMC regulatory subject matter experts to ensure innovative robust fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-pivotal development maximizing global regulatory success and minimizing time to clinical milestones.

Establish best practices and a strong regulatory community across Global Regulatory Affairs and CMC functions (process development analytical formulation drug substance/drug product device/combination where applicable quality clinical and manufacturing) to ensure consistent high-quality execution.

Serve as an influential leader internally and externally shaping early-development CMC regulatory policy influencing cross-functional decision-making and advancing adoption of in silico and digital approaches to product and process development across major regions (e.g. US EU Japan China).

How you will contribute:

• Leads and develops a team of regulatory leaders and subject matter experts overseeing global CMC regulatory strategy and key submissions/health authority interactions for an assigned portfolio of small molecule and biologic products through Phase 2.

• Partners with cross-functional leaders (CMC Regulatory Development Clinical Nonclinical Quality Safety Manufacturing Supply Chain and Digital/Data) to align CMC development plans to regional regulatory expectations and program timelines.

• Ensures governance teams and key stakeholders are apprised of CMC developments impacting regulatory success (e.g. process/formulation changes analytical readiness control strategy evolution comparability considerations starting material strategy impurity risk raw material/supply risk). Anticipates risks and drives mitigation plans consistent with quality risk management principles.

• Represents Global Regulatory Affairs CMC in senior-level governance and in interactions with global health authorities including FDA EMA MHRA PMDA and other agencies as applicable to enable efficient pathways for early development CMC strategies and submissions (e.g. pre-IND/IND/CTA amendments Type B/C meetings scientific advice).

• Accountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2 (e.g. IND/CTA modules IMPD quality sections amendments investigators brochure CMC and responses to health authority questions) partnering with regional leads and technical functions to ensure consistent inspection-ready documentation.

• Leads departmental and cross-functional initiatives to advance fit-for-phase and platform approaches in early development CMC including global harmonization of templates and positions improved knowledge management and readiness for accelerated programs (e.g. breakthrough/PRIME/RMAT where applicable).

• Provides CMC regulatory strategy leadership for business development and due diligence including assessment of early CMC maturity comparability risks prior knowledge leverage and global filing feasibility for small molecules and biologics.

• Monitors and anticipates global regulatory trends impacting early development CMC (e.g. ICH Q12/Q13/Q14/Q2(R2) nitrosamines elemental impurities biologics comparability emerging expectations for modeling/simulation and structured data) translating insights into proactive CMC development and submission strategies.

• Champions use of in silico approaches and digital capabilities in CMC (e.g. predictive impurity risk assessment process and formulation modeling PBPK/biopharmaceutics linkages where relevant digital data lineage and content re-use) to improve scientific justification reduce cycle time and strengthen global regulatory interactions.

• Responsible for demonstrating Takeda leadership behaviors.

Minimum Requirements/Qualifications:

• Advanced degree in a scientific or engineering discipline (e.g. MS PhD PharmD)

• 20 years of industry experience with significant experience in Global Regulatory Affairs CMC (or closely related CMC regulatory experience) including leadership for small molecule and/or biologic products in early development

• Significant experience leading reviewing authoring or managing CMC content for global regulatory submissions and responses in early development (e.g. pre-IND/IND CTA/IMPD amendments briefing packages and major deficiency responses) and negotiating requirements with health authorities

• Strong working knowledge of small molecule and/or biologic CMC development and global regulatory requirements including ICH guidance and regional expectations (FDA EMA MHRA PMDA); experience across additional regions a plus.

• Understands and interprets complex technical nonclinical clinical and manufacturing issues across multiple programs as they relate to CMC regulatory requirements and strategy including impurity risk analytical control strategy specifications stability strategy and comparability (as applicable).

• Demonstrated ability to drive fit-for-phase global CMC regulatory strategy leveraging prior knowledge platform capabilities and risk-based approaches; experience integrating in silico modeling/simulation and digital data strategies into CMC development and regulatory justifications is strongly preferred.

• Strong oral and written communications managing and adhering to timelines negotiation skills integrity and adaptability.

• Demonstrated ability to think strategically and operate with increasing independence understanding implications across the organization and globally; proactively identifies CMC regulatory issues and offers innovative risk-based solutions and mitigation strategies.

• Must work well with others and within global teams.

• Able to bring working teams together for common objectives.

• Acceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies including risk mitigation strategies.

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.

#LI-Hybrid

#LI-AA1

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.

Locations

Worker Type

Worker Sub-Type

Time Type

Job Exempt