Regulatory Affairs Sr. Manager - CMC China
About the Job
Amgen is seeking a Regulatory Affairs Senior Manager - CMC. Location for this position is flexible, and could include: Thousand Oaks, Singapore, China or remote location.
- Responsibilities of the Senior Manager Regulatory Affairs:
- Responsible for generation of China specific regulatory documents Clinical Trial Application and Marketing Authorization (CTAs and MAAs) and regulatory intelligence for multiple products.
- Primary point of contact and interface with Regional Regulatory Lead (RRL) and Local Regional Representative (LRR), and or collaboration partners for China
- Support the RA CMC Global teams with Clinical Trial initial applications and amendments, and future Marketing Application preparation including development of China specific strategic plan, data requirements and country specific requirements for China.
- Work within the Amgen document management system (VEEVA based) for the compilation of submission documents, tracking of submissions and approvals dates, and response to question preparation
- Facilitate product development and global registration by developing and executing regulatory strategies for product manufacturing and quality programs throughout product lifecycle.
- Contribute to the development of the Regional RA CMC strategy and execute the preparation of CMC components of CTA and NDA filings for Amgen and partnered products in collaboration with regional RA CMC and collaboration partners
- Responsible for organization and preparation CMC investigational product amendments and post-market supplements in collaboration with Amgen/Partner RA CMC Global Leads.
- Ensure appropriate compliance with archiving/tracking and monitor metrics utilizing a VEEVA based regulatory information management system.
- Oversee all regulatory obligations in relation to the region under responsibility, work with the team and cross functionally to ensure any necessary alignment to these obligations.
- Conduct contingency regulatory planning/risk assessment for regional development and regulatory interaction strategies.
Doctorate degree & 2 years of Regulatory and/or Compliance experience
Master’s degree & 6 years of Regulatory and/or Compliance experience
Bachelor’s degree or & 8 years of Regulatory and/or Compliance experience
Associate degree & 10 years of Regulatory and/or Compliance experience
High school diploma / GED & 12 years of Regulatory and/or Compliance experience
- CMC-specific regulatory knowledge & experience, including familiarity with CFDA requirements for clinical, commercial and post approval CMC submissions, as well as NIFDC registration testing
- Strong & effective oral and written communication skills; proven ability to communicate effectively with different management levels.
- Competent with Microsoft Outlook/ Word/ Excel/Power Point/Project
- Ability to speak and read Mandarin
- Experience working in manufacturing, analytical testing (QC/QA), process development in the Pharmaceutical/Biotech industry
If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.
Amgen, a biotechnology pioneer, discovers, develops, and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
Our culture is what makes Amgen a special place to work. We have a powerful shared purpose around our mission – to serve patients. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment, and inclusion in all that we do.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.