Associate Director, Regulatory Strategy
1 week ago
As an Associate Director, Regulatory Strategy, you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
ICON is partnering with one of the industry’s rapidly growing, dynamic Biotech. Their truly entrepreneurial and bold approach is successfully driving to market ground
- breaking treatments within the Autoimmune disease portfolio.
Their rapid growth strategy means you will need to be hands on, inventive in nature and highly collaborative to get things done.
- **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
- Excellent command of Mandarin and English
- 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
- 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.
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