Amgen Senior Manager CMC Regulatory Affairs in Thousand Oaks, California
Amgen is seeking a Regulatory Affairs Senior Manager-CMC. This position will be located in either the Thousand Oaks or San Francisco, CA locations or could be remote (US).
Responsibilities of the Senior Manager Regulatory Affairs:
Responsible for generation of the region 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 the Regional Regulatory Lead (RRL) and Local Regional Representative (LRR) for specific strategies or activities that impact a specific region.
Support the RA CMC Global teams with Clinical Trial initial applications and amendments, and future Marketing Application preparation.
Work within the Amgen document management system 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 all Amgen products in collaboration with the RRL and RA CMC JAPAC Regional lead
Responsible for organization and preparation 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.
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
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 one or more of the following languages: Mandarin, Japanese, Korean,
Experience in manufacturing, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech industry
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.