Regulatory Affairs Senior Manager - CMC Global - Thousand Oaks, CA | Biospace
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Regulatory Affairs Senior Manager - CMC Global

Amgen

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Location:
Thousand Oaks, CA
Posted Date:
2/13/2017
Position Type:
Full time
Job Code:
R-31766
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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

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Requirements

Basic Qualifications

Doctorate degree and 2 years of Regulatory and Compliance and/or Safety experience

OR

Master's degree and 6 years of Regulatory and Compliance and/or Safety experience

OR

Bachelor's degree and 8 years of Regulatory and Compliance and/or Safety experience

OR

Associate's degree and 10 years of Regulatory and Compliance and/or Safety experience

OR

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 project management techniques

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.)