Regulatory Affairs Planning resource I

  • location: Northbrook, IL
  • type: Contract
  • salary: $55 - $67.57 per hour
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job description

Regulatory Affairs Planning resource I

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. We are currently partnering with a company known for their leading clinical trials as well as Research & Development. With the goal to constantly develop innovative products, you will feel secure in the fact that you are making a difference. Apply for your dream job now!

 
location: Northbrook, Illinois
job type: Contract
salary: $55.00 - 67.57 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Assist with and manage activities related to the assessment of CMC regulatory dossiers, technology transfer, and regulatory submissions of products.
  • Remediate product specific regulatory documentation in alignment with globally registered information, internal product specifications, current global GMP regulations and requirements.
  • Activities include: CMC internal documentation and global regulatory submission review, gap assessment, risk assessment, internal document remediation and preparation of CTD sections for US and Latin America marketed products.
  • Review NDAs and Drug Master Files (DMF) for compliance to company specifications, federal and United States Pharmacopoeial (USP) guidelines.
  • Review including evaluation of analytical procedures and methodology, manufacturing processes and controls, and container closure, etc.
  • Knowledge of Documentum type regulatory systems.
 
qualifications:
  • Knowledge of Documentum type regulatory systems.
 
skills: CMC, NDA, Regulatory Affairs Operations, Submissions, 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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