Select Opportunity FOR A Regulatory Affairs Manager
Chelmsford , MA 1824
Posted 3 months ago
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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..
- 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.
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