Regulatory Information Specialist IV

South San Francisco, California | Contract

Post Date: 11/02/2017 Job ID: 3520 Industry: Regulatory Affairs

Our client is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. They  are among the world' s leading biotech companies, with multiple products on the market and a promising development pipeline.

 

Duties:
  • The combination product contractor within the Technical Regulatory (PTR) organization will be responsible for developing and executing regulatory strategies and initiatives for combination products

 

Primary responsibilities:
  • Lead the development and implementation of global regulatory strategies for combination products and devices
  • Manage the preparation and submission of briefing packages and CMC sections of IND/IMPD and BLA/NDA/MAA, including responses to questions from health authorities. Responsible for timely compilation of all necessary CMC documents to support technical contents of regulatory submissions
  • Serve as a combination product and device regulatory subject matter expert in Roche/Genentech. Provide regular training internally to enhance organizational knowledge and capability related to combination products and devices
  • Build strong collaborations and relationships with internal stakeholders to ensure successful execution of regulatory submissions
  • Stay abreast of changing regulatory requirements relevant to combination products/devices. Analyze regulations, rules, or guidance documents and communicate potential impact to internal stakeholders
  • Contribute to the newly created PTR combination product group' s vision, strategy, roadmap, and activities

Skills:

  • A minimum of 7 years of industry experience in regulatory, manufacturing, or quality related field in the medical device and/or biopharmaceutical industry, including applicable experience with combination products or medical devices
  • Experience on implantable device is preferred
  • Knowledge of ICH guidance documents and health authority regulations/standards relevant to combination products or medical devices, specifically 21 CFR part 4, 21 CFR part 820, 21 CFR part 803, IEC 62633, ISO 13485, Unique Device Identifier (UDI), and EU Medical Device Regulation
  • Knowledge of software regulatory requirements and technical standards (IEC 62304)
  • Knowledge of vigilance reporting requirements (postmarket safety reporting, medical device reporting, etc.) • Excellent communication, collaboration, and interpersonal skills
  • Dynamic personality, ability to think outside the box and take smart risk
  • Ability to think “big picture” and focus on details
  • Effective problem solving and strong organizational skills, including ability to prioritize tasks
  • Drive for continuous improvements and operate with lean mindset

 

Education: 

  • Must have a scientific degree, an advanced degree desired
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