Amgen Director Regulatory Affairs in Thousand Oaks, California
Amgen is seeking a Director Regulatory Affairs to work out of their Thousand Oaks, CA location.
The Regulatory Affairs Director is the lead of a regional Regulatory Affairs organization within assigned therapeutic areas.
The responsibilities of the Director Regulatory Affairs are:
To provide management and leadership by advising on the development and execution of regulatory strategy in JAPAC including plans for regulatory agency interactions.
To provide regulatory advice into JAPAC regional portfolio activities in support of short, medium and long-term business goals and to enable regional prioritisation of such portfolio (applicable to early development, registration and life cycle management).
To ensure appropriate regulatory input is provided into regional regulatory plans.
To provide oversight of Regional Regulatory Leads in technical procedures of regional regulatory activities.
To line manage Regional Regulatory Leads for designated therapeutic areas.
To manage forums for sharing of best practices and lessons learned related to regional regulatory activities.
To actively contribute to and reflect on needs for improved regulatory related processes and systems.
Interact with Global Regulatory Leads (GRLs) and other Product Team members for managing and resolving cross-functional issues.
Interact with JAPAC or Thousand Oaks stakeholders depending on location for inputs into management and resolution of cross-regional issues.
Execution of the regional regulatory product strategies.
Providing inputs into the regional Portfolio planning activities.
Advising the regional regulatory leads on regulatory agency considerations in strategy development.
Ensuring support of Global Regulatory Team (GRTs) and managing resources.
Ensuring regional regulatory needs are well defined and implemented.
Promoting compliant implementation of process changes, promoting communication of new regulatory process improvements ideas coming from users (i.e. RRLs and other reg functions).
Continue to support AABP patient safety
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
10+ years of biopharma regulatory experience
Experience at filing strategy development as well as negotiation strategy with agency.
Ability to lead and build affective teams
Strong communication skills - both oral and written
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
Conflict management skills
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.