Regulatory Affairs Director – In-vitro Diagnostics
Posted: January 12, 2017
Reference ID: R-23143
Amgen is searching for a Regulatory Affairs Director. This role can be based on our main corporate campus in Thousand Oaks, CA. It will report to our Executive Director of Regulatory Affairs.
The Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and lifecycle management of all Amgen molecules. This Director is in a product facing role that leads the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
Essential responsibilities include:
Lead one or more GRTs within Amgen's GRA department.
Develop and execute regulatory strategies for in vitro diagnostics and companion diagnostics
Develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions.
Provide regulatory expertise and guidance to product teams (eg, PST.)
Develop and execution of the global regulatory product strategy.
Lead global regulatory team(s).
Represent GRA on the PST and other key commercialization governance bodies.
Develop Global Regulatory Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan.
Represent GRA on PST to ensure development of product registration strategies and development plans aimed at achieving regulatory approval and product labeling.
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance and precedent.
Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance.
Lead the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes).
Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents).
Monitor and assess impact of relevant global regulations, guidance's, and current regulatory environment.
Ensure guidance on regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, conditional /accelerated approval, compassionate use and pediatric plan) are assessed and incorporated into the global regulatory strategy.
Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood.
Produce strategies that provide innovative alternatives which communicate the associated risks.
Communicate Amgen's position consistently cross-functionally and across all documents.
Develop the ability to articulate and educate the likelihood of regulatory success based on proposed strategies.
Develop ability to accurately predict expectations and outcomes by regulatory agencies.
Direct global regulatory agency interaction strategies, in collaboration with regional colleagues.
Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams).
Attend key regulatory agency meetings which could impact the global product strategy.
Lead GRT to develop and execute team goals. Integrate regional regulatory representative input into GRT and regulatory plans.
Represent GRA on key commercialization teams (e.g, PST, GDT, GST).
Represent Amgen GRA on external partnership teams at the PST level.
Provide education and training on regulatory strategies and compliance issues to other functions.
Ensure regulatory compliance for product.
Doctorate degree and 4 years of Regulatory and Compliance experience
Master's degree and 8 years of Regulatory and Compliance experience
Bachelor's degree and 10 years of Regulatory and Compliance experience
Global filing experience or a lot of Regional filing experience
In vitro diagnostics and companion diagnostics experience
Oncology experience. Biotech or Pharma experience
Experience working on multiple projects, late stage as well as early programs and products
Demonstrated ability to lead teams
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and mitigate against future strategic issues & uncertainties
Ability to resolve conflicts and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities. Managing multiple activities
Making complex decisions
Problem solving abilities
Dealing with ambiguity
Building effective teams
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.