Associate Director, Regulatory Chemistry, Manufacturing and Controls (CMC)

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Associate Director, Regulatory Chemisty, Manufacturing and Controls (CMC) will be responsible for leading the preparation of CMC documentation for submissions for our large molecule therapeutic drug candidates throughout their clinical development towards marketing approval and their post-approval stage. In this role you will have a front seat in the development and life-cycle management of novel therapeutics and to weigh into CMC development strategies.

What you will be doing:

• Contributes to the CMC development and life-cycle management of clinical and commercial stage programs in close collaboration with the CMC team members by:
• Lead the preparation of CMC documentation for China clinical and commercial dossiers, in development in close collaboration with external and internal stakeholders;
• Lead CDE consultation meetings and interactions from CMC perspective and lead preparation of scientific briefing documents and regulatory response documents with support of the global CMC team;
• Lead life cycle management of China dossiers relating CMC according to regional needs;
• Responsible for assessing regulatory impact of CMC change controls on China dossiers, and strategizing variation filing;
• Ensure submission packages are complete and compliant with applicable regulatory and country specific requirements;
• Oversee activities in relation to local QC testing, with support of the global CMC analytical team;
• Coordinating activities with external and internal partners ensuring that deliverables are executed with the right priorities and to the required standards;
• Providing strategic input into CMC development activities;
• Tracking execution of regulatory commitments.

Qualifications Needed:

• Master degree or PhD in biotechnology, pharmaceutical sciences or bio-engineering, with relevant expertise in CMC development and CMC Regulatory Affairs
• Science oriented, experience with large molecules is a plus
• Excellent regulatory writing skills coupled with comprehensive knowledge of pharmacopoeial requirements, ICH guidelines, China, FDA and EMA/CHMP regulations and guidelines, and other international regulatory requirements
• Team player; able to build effective relationships with internal and external stakeholders
• Well organized and able to handle multiple assignments in parallel
• Eye for detail and quality conscious attitude
• Hands-on, self-initiative, Proactive – can do mentality

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.