- Amgen is seeking a Director Regulatory Affairs 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 several 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 Director Global Regulatory Affairs position are:
- Develop and execute 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.
- Interact with Global regulatory agency 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.
- 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
- 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- Masters degree
- 3-5 years of recent Oncology 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
- Setting priorities
- Dealing with ambiguity
- Organizational savvy
- Action orientated
- Conflict management skills
- Negotiation skills
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