Regulatory Affairs CMC Manager

Overview

WE PUSH THE BOUNDARIES OF MEDICINE.

LEAPING FORWARD TO MAKE PEOPLE SMILE

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’re 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.

Job Purpose

Provide regulatory leadership, strategy, project management and tactical support for assigned post-approval projects; represent CMC Regulatory Affairs on global teams as needed and Regulatory Affairs Functional Teams; remain current on regulatory requirements for relevant countries, particularly EMEA and LATAM markets; demonstrate excellent interpersonal skills and the ability to lead multiple tasks.

Responsibilities

Key Responsibilities:

• Support developing and creating global CMC regulatory strategies for multiple projects (mostly post-approval phase).
• Manage CMC related change controls to ensure high quality strategic advice and regulatory compliance.
• Support authoring and / or review regulatory CMC documents for submission to EMEA and LATAM, and/or other regulatory agencies.
• Support the preparation of formal CMC-focused meetings with regulatory health authorities
• Create and maintain the CMC portion of the Global Regulatory Strategy Document and provide strategic CMC input
• Identify and escalate potential Regulatory issues to management, conduct risk evaluations, and propose mitigation strategies.
• Develop and manage CMC submission authoring, review, and submission timelines.
• Research regulatory requirements to support CMC submissions or inquiries from functional groups.
• Lead Regulatory-CMC Intelligence process and remain current on changes in regulatory requirements and environment and be a resource to functional groups for regulatory information.
  
  

Qualifications

Position Requirements

• Degree in life sciences and relevant biological pharmaceutical experience
• Significant time in pharmaceutical Industry, development or life cycle management
• Experience in Regulatory Affairs-CMC and/or primary development experience in biologic drug substances and/or life cycle management of biologics
• Highly motivated and great attention to detail.
• Strong endurance to work under tight timelines and complex/ changing situatons.
• Excellent presentation and communication skills.
• Thinks strategic and can demonstrate leadership
• Standard computer proficiency
• Change controls
• Strong written and oral communication skills and the ability to interact effectively with cross functional project teams.
• This position may require up to a minimum of 10% business travel.
  
  

Kyowa Kirin International is an equal opportunities employer. No agencies please.