This group's purpose is to facilitate product development and global registration by developing and executing regulatory strategies for product manufacturing and quality programs throughout product lifecycle. The RA CMC Asia Pacific lead is responsible for the planning, management, coordination and execution of regulatory submissions for products within the JAPAC Regional portfolio according to the approved filing plan in compliance with corporate standards, and local regulatory requirements.
The RA CMC Asia Pacific Lead is the primary point of contact and interface with the Regional Regulatory Lead (RRL) and Local Regional Representative (LRR) for specific strategies or activities that impact product development within the region. The RA CMC Asia Pacific lead will support the RA CMC Global teams with Clinical Trial applications, amendments, and future Marketing Application preparation. The position requires working within the Amgen document management system for the compilation of submission documents, tracking of submissions and approvals dates, and response to question preparation.
Additional responsibilities of the role include:
- Contribute to the development of the Regional RA CMC strategy
- Execute the preparation of CMC components of CTA and NDA filings for all Amgen products in collaboration with the RRL and RA CMC JAPAC Regional lead
- Organize and prepare CMC investigational product amendments and post-market supplements in collaboration with RA CMC Global Lead
- Ensure appropriate compliance with archiving/tracking and monitor metrics from tracking systems including IMR
- 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
Master's Degree and 3 years of Regulatory CMC & Compliance and/or Quality experience
Bachelor's Degree and 5 years of Regulatory CMC & Compliance and/or Quality experience
Associate's degree and 10 years of Regulatory CMC & Compliance and/or Quality experience
High school diploma/GED and 12 years of Regulatory CMC & Compliance and/or Quality experience
- Degree in Life Science.
- Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry.
- Regulatory CMC experience. CMC-specific regulatory knowledge & experience
- Strong & effective oral and written communication skills
- Proven ability to communicate effectively with different management levels
- Microsoft Outlook/ Word/ Excel/Power Point/Project
- Language: ability to speak and read one or more of the following language preferred: Mandarin, Japanese, Korean, Taiwanese
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.