:
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 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 dossiers relating CMC according to regional needs;
· Responsible for assessing regulatory impact of CMC change controls on 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
Sr Manager level with experience on IMPD for different regions, experience with CN CTAs is a plus
The new team members will be working on various regions / projects and not limited to China.
Qualifications:
· 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;
· Fluent in English – our working language;
What we offer:
At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.