Director, Regulatory Affairs CMC

About the role

Taiho Oncology is seeking a Director for Regulatory CMC to join our dynamic and expanding mid-size company. Reporting to the Executive Director, Regulatory CMC, you will manage global regulatory CMC activities for Taiho Oncology Inc. projects, providing strategic regulatory guidance and ensuring compliance with global regulatory requirements.

Responsibilities

• Manage global regulatory CMC activities for Taiho Oncology Inc. projects, including NDA's, MAA's, INDs, CTAs, DMFs, ASMFs, etc.
• Develop and prepare high-quality regulatory submissions and ensure they conform to current GMP and meet global regulatory requirements.
• Participate in interactions and negotiations with regulatory authorities during the drug development and approval processes.
• Develop and implement CMC regulatory strategies and risk assessments for early and late-stage development products.
• Lead, coordinate, and prepare CMC submissions to regulatory authorities globally except Asia.
• Review submissions for regulatory compliance and completeness.
• Ensure development strategies meet global regulatory requirements over the lifecycle of the TOI programs.
• Keep abreast of current global regulations and guidelines.

Requirements

• Bachelor’s degree in pharmacy, chemistry or related scientific discipline or equivalent experience is required.
• MSc, PhD or PharmD preferred.
• Technical and scientific expertise in a discipline related to pharmaceutical development, manufacturing, or quality.
• Fifteen years’ previous CMC drug development and regulatory experience (both US and EU).
• Substantial experience leading and preparing CMC documentation for regulatory filings.
• Experience in developing and implementing CMC regulatory strategy for early and late stage of development products with strong emphasis of approval through launch to post marketing commercial support.
• Knowledge of and experience interacting and negotiating with regulatory agencies, particularly the FDA.
• Previous experience in pharmaceutical development and manufacturing and management of CROs is desirable.
• Strong working knowledge of global CMC regulatory requirements and submission processes.
• In-depth knowledge of global regulatory requirements for pharmaceutical development and manufacturing.
• Strong working knowledge of current Good Manufacturing Practices (cGMP).
• Detail orientation, with emphasis on accuracy and completeness.
• Excellent written and oral communication.
• Ability to reason, persuade and negotiate with regulatory authorities.
• Good organizational and planning skills; drive for results.
• Good interpersonal skills that involve working well in a team environment and the ability to lead others.

Qualifications

• Strong working knowledge of global CMC regulatory requirements and submission processes.
• In-depth knowledge of global regulatory requirements for pharmaceutical development and manufacturing.
• Strong working knowledge of current Good Manufacturing Practices (cGMP).
• Detail orientation, with emphasis on accuracy and completeness.
• Excellent written and oral communication.
• Ability to reason, persuade and negotiate with regulatory authorities.
• Good organizational and planning skills; drive for results.
• Good interpersonal skills that involve working well in a team environment and the ability to lead others.