Regulatory Affairs Mgr – CMC Asia Pacific Lead
US – California – Thousand Oaks
Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.
Amgen is seeking a Regulatory Affairs (RA) Manager – Chemistry, Manufacturing and Controls (CMC) Asia Pacific Lead who will be located in our Thousand Oaks, CA office reporting to Regulatory Affairs Director.
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 for Clinical Trial applications, Marketing Applications, and life cycle management changes.
Additional responsibilities of the RA CMC Asia Pacific Lead include:
- Contribute to the development of the Regional RA CMC strategy and 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.
- Manage and coordinate life-cycle management changes for post approval variations across the region.
- Document Archiving: 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 & 3 years of Regulatory CMC & Compliance and/or Quality experience
Bachelor’s Degree & 5 years of Regulatory CMC & Compliance and/or Quality experience
Associate’s degree & 10 years of Regulatory CMC & Compliance and/or Quality experience
High school diploma/GED & 12 years of Regulatory CMC & Compliance and/or Quality experience
- MS 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.
- Experience with: Microsoft Outlook/ Word/ Excel/Power Point/Project.
- Language: ability to speak and read one or more of the following languages but not mandatory: Mandarin, Japanese, Korean, Taiwanese.
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.
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