Executive Director, Global Regulatory Affairs CMC Early Development

About the role

The Executive Director, Global Regulatory Affairs CMC Early Development is responsible for providing strategic and people leadership to deliver innovative, compliant global CMC regulatory strategies and submissions for small molecule and biologic products through Phase 2 development.

Responsibilities

• 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 from FIH to pre-pivotal.
• Promotes alignment of CMC development plans with regional regulatory expectations and program timelines.
• Ensures governance teams and key stakeholders are informed of CMC developments impacting regulatory success and drives mitigation plans.
• Represents Global Regulatory Affairs CMC in senior-level governance and interactions with global health authorities, including FDA, EMA, MHRA, PMDA, and other agencies as applicable.
• Guarantees global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2.
• Led 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.
• Provides CMC regulatory strategy leadership for business development and due diligence, including assessing early CMC maturity, comparability risks, prior knowledge leverage, and global filing feasibility.
• Maintains awareness of global regulatory trends impacting early development CMC and translates insights into proactive CMC development and submission strategies.
• Champions the use of in silico approaches and digital capabilities in CMC to improve scientific justification, reduce cycle time, and strengthen global regulatory interactions.

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
• Strong working knowledge of small molecule and/or biologic CMC development and global regulatory requirements, including ICH guidance and regional expectations
• Demonstrated ability to drive fit-for-phase global CMC regulatory strategy, leveraging prior knowledge, platform capabilities, and risk-based approaches

Skills

• Comprehensive understanding of global CMC regulatory requirements and expectations for small molecule and biologic development through Phase 2
• Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity, and adaptability
• Strategic thinker with the ability to identify and offer innovative, risk-based solutions and mitigation strategies

Benefits

Takeda offers competitive compensation and benefits, including:

• Base Salary Range: $238,000.00 - $374,000.00
• Short-term and long-term incentives
• Health, dental, and vision insurance
• Flexible spending accounts
• Retirement savings plan
• Employee assistance program
• Professional development opportunities

Pay

$238,000.00 - $374,000.00 U.S. Base Salary Range

Schedule

Hybrid work schedule