Global Regulatory Affairs CMC Specialist
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.
The Global Regulatory Affairs CMC Specialist will be responsible for: 1) representing CMC Regulatory Affairs as the change control coordinator for CMC regulatory, ensuring changes are progressed in a timely and compliant manner. 2) 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. 3) Act as a liaison with the Tech Ops organization.
Location: Lexington, Massachusetts
Duration: 4-month contract
Compensation: $65-70 per hour
- Education: Bachelors of Nursing, B.S or M.S in biochemistry, biology, engineering or related pharmaceutical field.
- Minimum of 2-4 years of drug development experience previous experience in regulatory and/or quality preferred
- Ability to work successfully with cross-functional teams and influence appropriate plans and actions.
- Strong attention to detail, establishing priorities, scheduling and meeting deadlines.
- Ability to work independently, take initiative and complete tasks to deadlines.
Sthree US is acting as an Employment Business in relation to this vacancy.