Overview

At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We are an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work.

🚀 Join Our Team as Director of Regulatory Affairs – CMC at Kyowa Kirin

Are you ready to lead the charge, managing the entire regulatory lifecycle of our diverse portfolio of groundbreaking products? You will have the exciting and unique opportunity to simultaneously work on Biologics, Small Molecules, and Drug/Device combinations, where your expertise impacts not just a company, but the future of healthcare.

Responsibilities

Your Responsibilities:

• Innovative Strategy Development: Forge global regulatory pathways for our diverse clinical projects, from inception to post-approval.
• Authority Engagement: Take the lead in high-stakes meetings with health authorities, driving negotiations and application reviews.
• Inspection Support: Offer your regulatory expertise to support our teams, with a hands-on approach, during critical authority inspections.
• Submission Mastery: Lead the CMC submission process, ensuring our groundbreaking products meet every regulatory note.
• Document Perfection: Craft and critique key regulatory documents with a keen eye, ensuring flawless submissions every time.
• Risk Communication: Be the beacon of foresight, alerting our teams to potential hurdles and devising smart strategies to overcome them.

Qualifications

Your Skills:

• Educational Foundation: Bachelors in a scientific field; advanced degree preferred.
• Industry Expertise: Extensive experience in pharmaceuticals and regulatory CMC.
• Technical Writing Champion: Ability to use technical information to create an informative and useable narrative for agencies.
• Analytical Proficiency: Skilled in data evaluation and setting clinical specifications.
• CMC Mastery: Deep understanding of drug substance/product development principles.
• Regulatory Acumen: Knowledge of CMC regulatory guidance and emerging sciences.
• Documentation Leadership: Experienced in authoring and managing CMC documentation for major biologic applications.
• Strategic Problem-Solving: Adept at issue identification, strategy development, and stakeholder negotiation.
• Technical Savvy: Proficient with MS Office Suite.

Apply now and become a pivotal part of Kyowa Kirin’s innovative legacy🌟