Regulatory Affairs Specialist III

  • location: Swiftwater, PA
  • type: Contract
  • salary: $37.23 - $43.80 per hour
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job description

Regulatory Affairs Specialist III

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

 
location: Swiftwater, Pennsylvania
job type: Contract
salary: $37.23 - 43.80 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Job Responsibilities

  • Candidate to author/review/approve CMC technical documents in the company's 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.
  • Provide regulatory guidance for development projets, post-approval CMC changes/variations.
 
qualifications:
Education & Qualifications

  • BS in Biology/Chemistry or related field
  • 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.
  • Prior regulatory experience
  • Technical writing experience (CMC experience )
  • Scientific background
  • CMC/ Regulatory writing experience - 3 + years authoring CMC regulatory documents including Module 2 and Module 2.
  • Vaccines preferredMicrosoft Office (word, excel, powerpoint)
  • Documentum/ Veeva Applications
  • Trackwise ApplicationsICH Guidelines
  • GMP experience
  • Experience with drug/biologics licensure preferred
  • Prior regulatory experience
**This position is working in the CMC area. Relevant experience is required

 
skills: CMC, Biology, Chemistry, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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