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Description US Medical Director, Medical Affairs MS In a matrix environment, the Medical Director for US Medical Affairs will perform a key role in the clinical ...
My client seeks a CMC Director to support small molecule development from research through Phase I/ Phase II clinical trials. The successful candidate will ...
Seeking excellent project management skills and scientific experience in the development of automated diagnostic assays. Shall: ** Work with big pharma customers ...
Manufacturer of established IVD platform with expanding market seeks executive level manager to lead project teams involved in the development of target based ...
Manage and direct the daily efforts of a world class scientific team designing and developing automated molecular assays for an in vitro diagnostic platform. ...
Seeking at least 5 years director level experience leading a scientific team designing, developing, validating, and commercializing molecular IVD assays to ...
Assume complete oversight of teams involved in design, selection, optimization, cataloging, and maintenance of recombinant mammalian cell lines. Shall: ** Provide ...
The Regulatory Affairs Manager is responsible for independently performing multiple activities in support of new development programs and Regulatory Affairs ...
Sr. Regulatory Affairs Associate The Sr. Regulatory Affairs Associate is responsible for independently performing multiple activities in support of specific ...
PRIMARY FUNCTION / PRIMARY GOALS / OBJECTIVES: Provide leadership and direction to the site in managing the overall effectiveness and coordination of the training ...
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
