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For your reference, we have included the original job posting below.
Dir Regulatory Affairs (CMC Site, Product Director)
Job Number:
43348453
Company Name:
Amgen
Job Location:
Woburn, MA US
Job Categories:
Science & Biotech Healthcare & Medical
Dir Regulatory Affairs (CMC Site, Product Director)
To facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
- Lead CMC development and global registration of biologic oncology therapeutic by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle for products manufactured at or planned for the specific site
- Responsible for execution and/or coordination of all global regulatory CMC activities, including providing leadership, guidance, and insight to oversee the successful execution and implementation of regulatory strategy - Communicate regulatory strategy, risks and issues to Regulatory and Operations senior management - Coordinates preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity - Responsible for the coordination of site-specific change control regulatory assessments with input from the CMC Product teams and the CMC Region representative
Key Activities: - Manage priorities and resources for one or more products; may act as product lead for complex product - Manage and develop direct reports - Provide strategic regulatory input and regulatory risk assessment for product teams - Executes regulatory strategy with respect to preparation of submissions - Complies with critical RA CMC processes - Identifies need for process and strategy changes to meet internal initiatives and changes in external regulatory policy and guidance - Reports needs for process changes to CMC systems and contributes to process improvements - Incorporates changes in external regulatory guidance into CMC strategy and guidance for product teams - Reports issues, progress and metrics to RA CMC product team management and/or RA CMC Functional Lead - May represent RA CMC on Operations steering committees and review boards - Accountable for the strategy and execution of the site-specific aspects of the preparation of CMC Investigational product amendments and post-market supplements, CMC sections of IND annual reports and annual reports of minor changes for specific products - Assure that site CMC acts a key RA CMC representative on product deviation investigation teams
Basic Qualifications - Doctorate degree & 4 years of directly related experience OR - Master's degree & 8 years of directly related years OR - Bachelor's degree & 10 years of directly related experience AND - 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Preferred Qualifications - Industry experience in manufacture, facility licensure, testing (QC / QA or clinical), vaccine development, import/export or distribution
