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A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
Take Regulatory CMC role for chemical products for marketed products in China. Work together with local CMC regulatory activities with internal and external stakeholders, prepare CMC dossiers for regulatory submission in China; working together with global CMC team for final dossiers review and approval.
- Working together with internal and external stakeholders to prepare CMC dossiers according to China registration regulation and guideline;
- Coordinate with global CMC experts to review and approve CMC dossiers for regulatory submission.
- Assess and communicate CMC regulatory requirements with internal partners to ensure all CMC submissions in compliance with applicable regulations and guidelines;
- Update the organization on the evolving CMC regulatory requirements to ensure all relevant divisions/functions understand the impact and implications and take appropriate actions;
- Engage and interact with regulatory agencies to reach aligned pathways/solutions for all CMC and QC related issues;
- Drive decision making through communication and alignment across multiple functions/divisions;
- Coordinate the preparation of CMC responses to regulatory agencies;
Who you are:
- Bachelor Degree or above in chemistry, or related pharmaceutical science;
- Experience in CMC areas such as formulation and analytical. At least 3 years of regulatory CMC experience.
- Knowledge in CMC regulatory requirement and ICH guidelines.
- Excellent organizational, interpersonal and communication skills (oral and written);
- Proven ability in cross-functional communication and alignment and ownership in resolving issues;
Functional Area: Regulatory Affairs
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology. We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.
North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
Notice on Fraudulent Job Offers
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