Regulatory Affairs Manager

  • location: Lexington, MA
  • type: Contract
  • salary: $53.45 - $62.88 per hour
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job description

Regulatory Affairs Manager

job summary:
Regulatory Affairs CMC Project Manager I

 
location: Lexington, Massachusetts
job type: Contract
salary: $53.45 - 62.88 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
Job Responsibilities

  • Manages multiple multi-product CMC focus global submission to ensure timely completion per established timelines.
  • In consideration of health authority requests & program plans, create project plans with documentation requirements, timelines, and identified and monitor activities of key deliverables.
  • Will work closely with project leads, but require the ability to work independently with minimal supervision.
  • Requires excellent verbal and written communication skills, must be able to manage concurrent projects that may be unplanned, detailed oriented, and organized.
  • May require internal and external interactions in support of project plans.
 
qualifications:
Education & Qualifications

  • Professional Degree and/or coursework (Chemistry, Biology, Biochemistry, Pharmacy, etc) and at least one year of regulatory related course work is preferred.
  • Proficient in MS Office and experience in databases and electronic system is highly desirable
 
skills: CMC, MS-WORD, MS-EXCEL, MS-Powerpoint, GCP (Good Clinical Practice), Regulatory Affairs Operations, Submissions, ICH Regulations
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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