Senior Manager CMC Regulatory Affairs
- Employer
- Amgen
- Location
- Thousand Oaks, CA, US
- Start date
- Nov 8, 2019
View more
- Discipline
- Regulatory, Regulatory Affairs
- Required Education
- High School or equivalent
- Position Type
- Full time
- Hotbed
- Biotech Beach, Best Places to Work
Job Details
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.
Basic Qualifications
Doctorate degree & 2 years of Regulatory and/or Compliance experience
OR
Master's degree & 6 years of Regulatory and/or Compliance experience
OR
Bachelor's degree or & 8 years of Regulatory and/or Compliance experience
OR
Associate degree & 10 years of Regulatory and/or Compliance experience
OR
High school diploma / GED & 12 years of Regulatory and/or Compliance experience
Preferred Qualifications
- 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
Join Us
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.
Company
We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.
We live the mission.
We win together.
We thrive on continual challenge.
Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.
At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.
Connect with us to explore how you can Win, Live, and Thrive at Amgen.
- Website
- http://careers.amgen.com/
- Phone
- 805-447-1000
- Location
-
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States
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