Select Opportunity FOR A Regulatory Affairs Manager

Vista Technology Chelmsford , MA 1824

Posted 3 months ago

REGULATORY AFFAIRS MANAGER

PRIMARY RESPONSIBILITIES WILL BE TO . . .

  • Oversee | Prepare global regulatory submissions (DMF, ASMF, etc.) in eCTD format describing the manufacturing and controls in support of ANDA and NDA submissions.
  • Provide regulatory oversight and be a resource as well as monitor global regulatory agency publications, proposed guidances, inspection reports and expectations to determine trends and areas of regulatory compliance.
  • Assist in ensuring site quality policies and procedures are compliant with state and federal requirements, including (but not limited) FDA, DEA, regional Board of Health Authorities etc..

BACKGROUND PROFILE:

  • Experience | expertise compiling DMFs.
  • Project Management skills (e.g. mapping, etc.) with a record of tracking and delivering multiple projects effectively and on-time.
  • Working knowledge of SOPs, cGMPs, ICH Guidelines (e.g. Q-7), etc.
  • Exposure to Pharmaceutical Development (e.g. Process Chemistry, Method Development, Analytical Testing).
  • 5+ years in the pharmaceutical industry.

Contact us now for additional details:

Call:978.686.2200 OR

Email:rich@vista-technology.comOR

Schedule a Time To Talk With The Recruiter:
https://calendly.com/richconnors

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Select Opportunity FOR A Regulatory Affairs Manager

Vista Technology