Job Details

  • Title: Regulatory Affairs Specialist
  • Code: RCI-03243
  • Location: Swiftwater Pennsylvania (PA) 18370
  • Posted Date: 11/11/2020
  • Duration: 12 Months
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  Job Description

Candidate will work on license conformance attributes with in Global Regulatory Affairs - CMC. In addition, the candidate will be tasked to author/review/approve CMC technical documents in internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Authorities.

Must have working knowledge of biologic/drug regulations (FDA, ICH, EU, etc) related to CMC. Must be able to provide regulatory guidance for development projects, post-approval CMC changes/variations. Must have working knowledge of GMPs. Must be well-organized, work with minimal management and meet aggressive timelines. Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.

Must also have extensive experience working in document management systems.

**This position is working in the CMC area. Relevant experience is required.

Skills
CMC/ Regulatory writing experience - 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3
Scientific background, vaccines preferred
Microsoft Office (word, excel, PowerPoint)
Documentum/ Veeva Applications
Trackwise Applications
ICH Guidelines
GMP experience
Experience with drug/biologics licensure preferred
Prior regulatory experience

Education
BS in Biology/Chemistry or related field.

Regulatory experience or even Quality. Position is more junior level, more of a doer. College educated with industry experience (manufacturing, devices, etc....). Experience working with documentation. Knowledge of Quality if they have Regulatory, or regulatory knowledge if they have quality background. Common Technical Document (CTD) knowledge. Will be reviewing licenses. Identify gaps, raise questions.