Executive Director, Global Regulatory Affairs CMC Early Development

About the role

The Executive Director, Global Regulatory Affairs CMC Early Development will lead and develop a team of regulatory leaders and subject matter experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products from FIH to pre-pivotal development. They will also establish best practices and a strong regulatory community across Global Regulatory Affairs and CMC functions.

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 consistent with quality risk management principles.
• 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, to enable efficient pathways for early development CMC strategies and submissions.
• Accountable for ensuring global CMC content quality and compliance for early development submissions and lifecycle changes through Phase 2.
• Advances 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 assessment of early CMC maturity, comparability risks, prior knowledge leverage, and global filing feasibility for small molecules and biologics.
• 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 (FDA, EMA, MHRA, PMDA)
• 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.

Skills

• Comprehensive understanding of global CMC regulatory requirements and expectations for small molecule and biologic development through Phase 2, including fit-for-phase control strategies, comparability, and risk-based approaches.
• 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.

Benefits

Takeda offers competitive compensation and benefits, including:

• Base Salary Range: $238,000.00 - $374,000.00
• Hybrid and Remote Work Policy

Pay

$238,000.00 - $374,000.00

Schedule

Full time