Amgen Regulatory Affairs Dir in Thousand Oaks, California
Amgen is seeking a Regulatory Affairs Director to work out of our Thousand Oaks, CA location. This position reports to the 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 role is a product facing role that leads the Global Regulatory Team (GRT) in the Regulatory Affairs organization.
The purpose of this role is:
To lead one or more GRTs and other regulatory staff within Amgen's GRA department.
To 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.
To provide regulatory expertise and guidance to product teams (eg, Product Strategy Team PST).
The Responsibilities of the Global Regulatory Affairs position are:
Develop and execute the global regulatory product strategy.
Lead global regulatory team(s) 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.
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, as appropriate.
Communicate consistently well defined, innovative regulatory strategies, risks and risk mitigations throughout the organization such that expected outcomes are understood.
Communicate Amgen's position consistently externally and across all documents.
Interact with Global regulatory agency, 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.
Provide education and training on regulatory strategies and compliance issues to other functions.
Doctorate degree and 4 years of Regulatory experience
Master's degree and 8 years of Regulatory experience
Bachelor's degree and 10 years of Regulatory experience
Ability to lead and build affective 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
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.