Regulatory Affairs Senior Manager – CMC Global

  • Company: Amgen
  • Posted: January 12, 2017
  • Reference ID: R-31766
As a result of a significant number of late stage product development milestones, with several global marketing application filings, approvals and launches in the next few years, the Global Regulatory Affairs CMC function is currently recruiting for a Regulatory Affairs Senior Manager.
This is an opportunity to further a regulatory career at the largest independent biotechnology company, a scientific leader and innovator in the sector, and to lead or support regulatory CMC strategy and execution for exciting new products which offer great promise to patients with grievous illnesses and unmet medical needs. Amgen's portfolio of biologically and synthetic derived CMC technologies also offers fantastic Industry-leading scientific, technical and regulatory experiences.
This RA CMC Senior Manager position is a fantastic opportunity to Lead the development and execution of robust, risk-based regulatory strategies for high profile programs, mentor and provide direction to more junior team members, and contribute to functional initiatives including external policy advocacy and process improvement.
Key responsibilities:
Responsible for developing and communicating regulatory strategy, risks and issues to Regulatory and Operations senior management, and accountable for execution of the strategy
Coordinates communication and collaboration with the site and regional RA CMC network to develop and execute global regulatory activities
Accountable and responsible for all FDA interactions on CMC matters, including Agency meetings
Contributes to one or more product teams; may act as product lead for one or more products
Provides strategic regulatory input and regulatory risk assessments for product teams
Provides mentoring oversight and assigns work to more junior RA CMC staff
Complies with critical RA CMC processes
Executes, or is accountable for the execution of, regulatory strategy with respect to preparation of submissions and other regulatory deliverables
Identifies need for process and strategy changes to meet internal Amgen 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
Basic Qualifications
Doctorate degree and 2 years of Regulatory and Compliance and/or Safety experience
Master's degree and 6 years of Regulatory and Compliance and/or Safety experience
Bachelor's degree and 8 years of Regulatory and Compliance and/or Safety experience
Associate's degree and 10 years of Regulatory and Compliance and/or Safety experience
High school diploma / GED and 12 years of Regulatory and Compliance and/or Safety experience
Preferred Qualifications
Experience in manufacture, testing (QC/QA or clinical), or distribution
Regulatory CMC experience, specifically: 6+ years of regulatory or CMC experience (site, product or regional); Strong submission contributions and/or submission coordination (CTAs, MAs, variations, briefing documents, etc.); Global Regulatory strategy development; Functional presentations; System and Process competency (EPIC/IMR/CCMS); X-functional team membership; Regulatory Project Management; Regulatory intelligence and policy analysis; Change assessment support; NPI support
Specialized knowledge within own specialty area of regulatory CMC
Detailed knowledge of international regulations and guidance
Expanding knowledge and understanding of business trends and objectives
Experience leading critical projects in a global complex matrix environment
Strong interpersonal and organizational skills
Strong project management techniques
Strong collaboration and leadership skills
Experience managing cross-functional product and business initiatives
Expanding knowledge of strategic management models and frameworks
Attention to detail
Relationship building
Deep understanding of Amgen's commercialization process
Core foundation of drug/device manufacturing
Core foundation of drug change control assessments and process
Core foundation of Amgen processes and systems for regulatory submission (GMAP, CCMS, etc.)
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
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.

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