regulatory in lexington

job type
US$ 45.32 per hour
apply now

job details

lexington, massachusetts
job category
Biotechnology & Pharmaceutical
job type
US$ 45.32 per hour
reference number
apply now

job description

GRA CMC Manager

Job Summary

Reporting the Associated Director of GRA CMC Compliance, the incumbent will assist in the management of change controls for the CMC regulatory affairs group for all biological, plasma and/or small molecule products. This will include formulating and implementing CMC regulatory strategies with the global regulatory and international regulatory leads. This person will also act as a liaison with the Tech Ops organization.

Job Responsibilities

  • Provide collaborative support for execution of global change control strategies to US and other regions (EU & International)
  • Tech Ops liaison
  • Project management from a GRA CMC perspective for several critical company projects
  • Represent CMC regulatory affairs as the change control coordinator for CMC regulatory and ensure changes are progressed in a timely and compliant manner(50%)
  • Collaborate and communicate with global CMC leads, EU and international regulatory colleagues to provide consistent, clear and timely assessments into the change control management system (50%)

Education & Qualifications

  • BN B.S / M.S in biochemistry, biology, engineering or related pharmaceutical field
  • 2-4 years of drug development experience previous experience in regulatory and/or quality preferred
  • Demonstrated leadership, strong communication and excellent organizational skills
  • Excellent interpersonal, communication, analytical and organizational skills.
  • Ability to work successfully with cross-functional teams and influence appropriate plans and actions.
  • Strong attention to detail, establishing priorities, scheduling and meeting deadlines.
  • Must be able to work in a fast paced environment with demonstrated ability to effectively manage multiple competing tasks and demands
  • Ability to work independently, take initiative and complete tasks to deadlines.


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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.