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For your reference, we have included the original job posting below.
Regulatory Affairs Mgr (Regional Representative)
Job Number:
44372157
Company Name:
Amgen
Job Location:
Thousand Oaks, CA US
Job Categories:
Science & Biotech Healthcare & Medical
Regulatory Affairs Mgr (Regional Representative)
This role will support one or more programs in the therapeutic Area team within Amgen's regulatory Affairs department. The Therapeutic Area team facilitates product development and global registration to achieve the desired regional labeling by developing and executing regulatory strategies and effective regulatory agency interactions.
- The Regional Representative, under direction of a Global Regulatory Leader (GRL) will assist in the execution of regulatory strategy.
Key responsibilities include: - Participate through the Global Regulatory Team, in the development of product label and core data sheet by collaborating with the labeling Working Group to define commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent
- Assist GDT to develop study protocols, reports, and development plans aimed at achieving regulatory approval and product labeling stat supports key messages
- Review and contribute to regional regulatory documents
- Assemble and provide timely regional regulatory input to GDT and other cross functional project meetings, consistent with GRT strategy
- Provide expertise and guidance on teams for interdepartmental and cross functional teams including, process improvement standards development and metrics
- Assist in the development of regional regulatory strategy
- Evaluate and communicate impact of relevant regional regulations, guidances, current regulatory environment and competitor labeling
- Provide guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies Orphan Drug, Fast Track, compassionate use and pediatric plan)
- Advise and support promotion group regarding applicability of data for product communication
- Contribute to creation and maintenance of product regulatory history documents through IMR and appropriate archiving of all regulatory documents and agency communications
Basic Qualifications - Doctorate degree OR - Master's degree and 3 years of directly related experience OR - Bachelor's degree and 5 years of directly related experience OR - Associate's degree and 10 years of directly related experience OR - High school diploma / GED and 12 years of directly related experience
Preferred Qualifications - Regulatory submissions experience - Experience interacting with regulatory agencies - Strong communications skills, both oral and written - Ability to understand and communicate scientific/clinical information
