Prothena

Associate Director/Director, Regulatory Affairs (Head of Regulatory Operations)

US-CA-South San Francisco
Job ID
2017-1216
Category
Research & Development

Overview

Reporting to the Director of Regulatory Affairs, and in accordance with the goals of the company, and applicable regulations, standards, and established procedures, the Associate Director/Director of Regulatory Affairs will be responsible for establishing and leading a global Regulatory Operations and Publishing group to support quality, timely regulatory submissions for all company products.

Responsibilities

  • Establish and lead a global Regulatory Operations function, to include management of publishing vendors
  • Define and execute strategies for Regulatory Information Management and Archiving systems, applications, and submissions for INDs/CTAs/BLAs/MAAs and required maintenance across products in the US and globally
  • Coordinate with Regulatory Medical Writing, IT, and other functional areas as needed to accomplish Regulatory Operations objectives
  • Serve as representative to Regulatory Agencies on technical aspects of eCTD/NeeS filings
  • Manage customization of INDs/IMPDs, BLAs/MAAs, SPL, and briefing dossiers, provide document formatting support, and organize submissions in a professional, compliant, high-quality, and timely manner
  • Provide leadership for all Regulatory Operations matters on the global Regulatory Affairs team
  • Develop and provide training on Regulatory Operations and publishing SOPs and best practices; support inspection readiness activities as needed
  • Maintain an effective archiving system
  • Maintain and expand current knowledge of regional regulatory publishing requirements and precedents that may affect company filings
  • Manage outsourced publishing activities, serving as point of contact to vendors
  • May supervise other regulatory staff

Qualifications

  • Bachelor’s degree in the life sciences; advanced degree preferred
  • Minimum of 7 years (Associate Director) to 10 years (Director) of Regulatory Affairs/Operations experience in the biotechnology/pharmaceutical industry, with at least 4 years in a leadership role
  • Extensive experience managing complex regulatory submissions (eg, eIND, NDA/BLA/MAA registration, and post-marketing/life-cycle management)
  • System administration experience with Veeva Vault or similar content management platform strongly preferred
  • Hands-on contributor willing to perform a wide variety of tasks to support business needs
  • Familiarity with EU and RoW CTA/CTN/MAA regulatory processes preferred (EMA Gateway and CESP knowledge would be an advantage)
  • Regulatory Project Management experience preferred
  • Ability to oversee regulatory publishing activities for teams based in the US and Ireland and develop/manage processes for handoffs from research/discovery, CMC, and clinical
  • Ability to build/forge relationships with key parties (e.g., FDA)
  • Excellent written and verbal communication skills

Competencies and Attributes:

  • Demonstrates Prothena’s core values – creative, courageous, selfless, and humor
  • Must possess excellent interpersonal skills
  • Must have the ability to build and maintain positive relationships with management, peers, and direct reports
  • Ability to build/forge relationships with key parties (e.g., Regulatory Agencies, Vendors)
  • Excellent written and verbal skills required. Must display strong analytical and problem solving skills. Attention to detail essential.

Travel requirements:

Up to 10% travel required: U.S. and Europe

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