Regulatory Affairs Director

US-WA-Seattle
Job ID
2018-1097
Category
Regulatory Affairs

Overview

The Regulatory Affairs Director will have 7-10 years experience, ideally with advanced cellular therapy products. The individual will be responsible for providing regulatory support and guidance to internal project teams, manage submissions for INDs, BLAs, Annual Reports, Labeling, etc. They work independently with direction from Regulatory Affairs senior management.

Responsibilities

  • Provide recommendations to Project Team or ad hoc committees with consultation by Regulatory Management on regulatory direction for development projects and approved products to be incorporated into the development strategy.       Recommendations are based on knowledge gained from direct FDA experience, previous submissions and FDA Advisory Committee meetings.
  • Provide regulatory advice and consultation for products within their responsibility to Senior Management for incorporation into the decision making process.
  • Establish and maintain regular and effective interface with FDA officials to acquire a knowledge base of regulatory requirements and strategy to enable Dendreon to efficiently and effectively shorten development and FDA approval times.
  • Prepare submissions of registration documents (INDs, BLAs, Orphan Product Designation Requests, etc.) with consultation by Regulatory Management.
  • Collects regulatory documentation from relevant departments to support submissions.
  • Reviews material for completeness, internal consistency with other documents, conformance to FDA regulations; assures readiness for submission by gathering missing information, resolving internal consistency and regulatory issues; compiles, with assistance from Document Management, high quality submissions that are fileable and meet all FDA requirements.
  • Prepare and submit documentation to FDA to support active INDs and approved marketing applications to protect clinical studies and approved products from FDA withdrawal and subsequent loss of sales and earnings.
  • Assure that the outcomes of meetings/teleconferences with FDA are clearly understood and agreed upon by all participants and communicated to appropriate individuals within set timeframe.
  • Assure that all interactions (verbal or written) with regulatory authorities reflect credible regulatory and corporate reputation.
  • Identify and clearly communicate all regulatory issues related to projects to Regulatory Management.

 

Qualifications

  • Bachelor’s degree in a scientific discipline or equivalent.
  • Prior drug development experience.  
  • Minimum 7 - 10 years related experience with cGMPs, FDA regulations, especially with advanced cellular therapy products.
  • Knowledge of cGMP/ICH/FDA regulations.
  • Ability to communicate effectively orally and in writing.
  • Functions independently.
  • Highly organized.
  • Capable of supporting numerous projects simultaneously.

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