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- Tasks: Lead CMC documentation for China submissions and collaborate with stakeholders.
- Company: Join a dynamic team focused on developing innovative therapeutics.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth.
- Why this job: Be at the forefront of drug development and make a real impact in healthcare.
- Qualifications: Master's or PhD in relevant fields with experience in CMC regulatory affairs.
- Other info: Fluency in English is required; apply today!
The predicted salary is between 54000 - 84000 £ per year.
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.
· 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
Apply today! http://jobs.thermofisher.com
CMC RA Senior Manager/AD China submissions employer: Thermofisher Scientific
Contact Detail:
Thermofisher Scientific Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CMC RA Senior Manager/AD China submissions
✨Tip Number 1
Familiarize yourself with the specific regulatory requirements for CMC submissions in China. Understanding the nuances of local regulations will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 2
Network with professionals in the CMC field, especially those who have experience with large molecules and China submissions. Engaging with industry experts can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Stay updated on the latest trends and changes in CMC regulatory affairs, particularly in China. This knowledge will be crucial during discussions and can set you apart as a well-informed candidate.
✨Tip Number 4
Prepare to discuss your previous experiences in CMC development and how they relate to the responsibilities outlined in the job description. Be ready to share specific examples that highlight your skills and achievements.
We think you need these skills to ace CMC RA Senior Manager/AD China submissions
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description and understand the key responsibilities and qualifications required for the Associate Director CMC China Dossier Development position. Tailor your application to highlight relevant experiences.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in CMC development and regulatory affairs, particularly in relation to large molecules and China submissions. Use specific examples to demonstrate your expertise.
Showcase Regulatory Writing Skills: Since excellent regulatory writing skills are crucial for this role, include examples of your previous work that showcase your ability to prepare CMC documentation and regulatory response documents.
Tailor Your Application: Customize your cover letter to reflect your understanding of the company's goals and how your background aligns with their needs. Mention your proactive approach and ability to build relationships with stakeholders.
How to prepare for a job interview at Thermofisher Scientific
✨Showcase Your CMC Expertise
Make sure to highlight your experience in CMC development and regulatory affairs, especially in relation to large molecules. Be prepared to discuss specific projects you've worked on and how they relate to the responsibilities outlined in the job description.
✨Demonstrate Regulatory Knowledge
Familiarize yourself with the relevant regulations and guidelines, such as ICH, FDA, and EMA/CHMP. During the interview, be ready to discuss how you have applied this knowledge in past roles, particularly in preparing submission packages and managing change controls.
✨Emphasize Team Collaboration
This role requires close collaboration with both internal and external stakeholders. Share examples of how you've successfully worked in teams, managed relationships, and coordinated activities to achieve common goals in your previous positions.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to handle multiple assignments. Think of scenarios where you had to prioritize tasks or navigate complex regulatory challenges, and be ready to explain your thought process and outcomes.
