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CMC RA Senior Manager/AD China submissions

Job Id R-01303563 Job Type フルタイム Category 品質・薬事 Remote ハイブリッド
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JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.
This a client dedicated role;

To further strengthen our CMC team, we are looking for an Associate Director CMC China Dossier Development. The candidate will be responsible for leading the preparation of CMC documentation for China 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.


Key Accountabilities and Responsibilities:

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:

· Master degree or PhD in biotechnology, pharmaceutical sciences or bio-engineering, with relevant expertise in CMC development and CMC regulatory affairs in China;

· 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.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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