CMC RA Senior ManagerAD China submissions
CMC RA Senior ManagerAD China submissions
Posted on :
16-02-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Job Description
Job Title: CMC RA Senior Manager/AD China submissions
Job Location: Great Britain United Kingdom
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level:
Work Schedule
Standard (MonFri)
Environmental Conditions
Office
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 lifechanging 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 postapproval stage. In this role you will have a front seat in the development and lifecycle management of novel therapeutics and to weigh into CMC development strategies.
Key Accountabilities and Responsibilities:
Contributes to the CMC development and lifecycle management of clinical and commercial stage programs in close collaboration with the CMC team members by:
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 awardwinning 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 wellbeing of our employees. We have a flexible working culture where PPD Clinical Research Services truly value a worklife 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 100000 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!
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.
Standard (MonFri)
Environmental Conditions
Office
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 lifechanging 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 postapproval stage. In this role you will have a front seat in the development and lifecycle management of novel therapeutics and to weigh into CMC development strategies.
Key Accountabilities and Responsibilities:
Contributes to the CMC development and lifecycle 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.
- Master degree or PhD in biotechnology pharmaceutical sciences or bioengineering 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;
- Handson selfinitiative Proactive – can do mentality;
- Fluent in English – our working language;
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 awardwinning 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 wellbeing of our employees. We have a flexible working culture where PPD Clinical Research Services truly value a worklife 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 100000 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!
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.
/jobs/view/f97c8cf56c9aa3934cf95478b18c53c9
Employment Type
Full Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
