Director Regulatory Affairs - Oncology
Ventura County, CA 91320
Location: Ventura County, CA
Job Category: Regulatory Affairs
Contact: Ken Kupersmith
Seeking a Director Regulatory Affairs to work out of offices in a suburb north of Los Angeles, CA. 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 company 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:
1.To lead several GRTs and other regulatory staff within company's GRA department
2.To develop a comprehensive regulatory strategy that takes into account worldwide regulatory
3.To provide regulatory expertise and guidance to Product Strategy Team (PST)
The Responsibilities of the Director Global Regulatory Affairs position are:
1.Develop and execute the global regulatory product strategy.
2.Lead global regulatory team(s).
3.Represent GRA on the PST and other key commercialization governance bodies.
4.Develop Global Regulatory Plan through integration of regional regulatory strategies and provide regulatory input into the Global Strategic Plan.
5.Represent GRA on PST to ensure development of product.
6.Registration strategies and development plans aimed at achieving regulatory approval and product labeling.
7.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.
8.Obtain input from the GRT members to develop a global regulatory strategy that supports product development, registration and lifecycle maintenance.
9.Lead the planning and implementing global regulatory filings (e.g. clinical trial applications, marketing applications, label extensions, CMC changes).
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
1.Masters or Doctorate degree
2.3-5 years of recent Oncology experience
3.Ability to lead and build affective teams
4.Strong communication skills - both oral and written
5.Ability to understand and communicate scientific/clinical information
6.Ability to anticipate and mitigate against future strategic issues & uncertainties
7.Cultural awareness and sensitivity to achieve global results
8.Planning and organizing abilities
9.Managing multiple activities
10.Making complex decisions
11.Problem solving abilities
14.Dealing with ambiguity
17.Conflict management skills