Associate Director Regulatory Affairs (Regulatory Strategy)

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Irvine, CA
$1 - $1
Job Type
Direct Hire
Nov 15, 2018
Job ID
Represents Regulatory Affairs for pharmaceutical development projects and marketed products. Responsible for development and communication of all aspects of global regulatory strategy on R&D project teams. 
Leads team of regulatory professionals to assure successful planning and completion of regulatory activities on a worldwide basis.  Responsible for knowledge of regulatory requirements of major regions (e.g. US, EU JP) with responsibility for working with colleagues on a worldwide basis to form a global strategy.  Responsible for content of global regulatory submissions.  Directs communications and interactions with US FDA and other regulatory agencies worldwide. Acts as primary contact for the US FDA.
Ensures technical accuracy and regulatory compliance of all submissions for which they are responsible and ensures that applications are executed appropriately and submitted on time.
May have responsibility to work in one or more therapeutic areas, covering multiple development projects.
Main Areas of Responsibilities
Advisory Responsibilities: Represents Department at Global Project Team.  Develops regulatory strategic plan and provides guidance to project team.  Leads Global Regulatory Team.  Works with team to resolve complex project issues.  Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained. Manage and mentor direct report(s), where line management responsibilities exist.
Project Execution: Sets strategy for submissions of product registration documents to health authorities worldwide.  Interacts with other line functions in the preparation, review, and completion of documents for regulatory submissions.   Responsible for US submissions (strategy and submission preparation).
Communications: Able to clearly articulate regulatory strategy at Global Project and Global Regulatory Team meetings.  Able to negotiate with team to assure acceptance of regulatory strategy.  Assures compliance with project team timelines and milestones. 
Health Authority Interactions: Effectively plan, organize, and conduct (or supervise) formal meetings with regulatory agencies.  Interact with key personnel in regulatory agencies to ensure the review and approval of development plans, the timely resolution of issues, and the approval of marketing applications.
Regulatory Compliance: Provide interpretive analyses of complex regulatory guidance documents, regulations, or directives that impact company products and operations. Advise personnel in other departments regarding their applicability and impact.
10 years of professional work experience required to include at min. 6 years of pharmaceutical drug regulatory affairs experience.
Preferred Skills/Qualification
  • Demonstrated excellence in developing global regulatory affairs strategy
  • Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams
  • Expert knowledge of US and ICH regulations. Experience with Japanese and Chinese regulations is a significant benefit.
  • Excellent interpersonal skills
  • Exceptional communication skills (verbal and written) as evidenced by a demonstrated ability to prepare complex documents / submissions and to give presentations
  • Experience working in a matrixed environment  
  • Ability to work independently
  • Ability to travel
BS degree required; Pharm.D./Ph. D preferred