Job Description The Sr. Regulatory Affairs Specialist will be responsible for writing, reviewing and submitting submissions. Incumbent will be the primary FDA contact. Experience in obtaining, maintaining and managing site accreditation with foreign health authorities as Korean FDA, Indian FDA and PDMA (Japan). *Write, review, compile and submit new drug master files\/CEP common technical documents and their submission with the relevant regulatory authorities *Review, compile and submit amendments, updates and updates to existing DMFs for filing with the relevant regulatory authorities *Manage documents and maintain all CCC regulatory filings with health authorities *Serve as primary site liaison with health authorities concerning regulatory filings (i.e. issue LOA\u2019s, responding to deficiency letters, requests for additional information\u2026.) *Serve as liaison with new and existing customers concerning regulatory filings (i.e. issuing CEPs, preparation and submission of Letters of Authorization, coordinate filings of EDMF\/CDMF with MAA, communicate changes and proposed changes, and coordinate responses to customer inquiries) *Obtain, maintain and manage site accreditation with foreign health authorities, Korean FDA, Indian FDA and PDMA (Japan) *Provide guidance and in-put to company project teams on regulatory requirements and guide compilation of DMFs\/Registration Dossiers *Review of various change controls for compliance to commitments made in Regulatory Submissions or requirements and complete assessments of regulatory impact *Provide regulatory council on new and existing raw material, in-process and product specification, and test methods *Review of data received from R&D, manufacturing, analytical, supply chain and quality assurance departments **If you\u2019d like to hear more about this opportunity and others we are currently working on, please contact Steve Sapita at 815.756.1221 [Click Here To Join]. JO: 559.17SS Job Requirements *Bachelor\u2019s degree in a life science discipline, chemistry preferred *M. Pharm. Or M.Sc.\/Ph.D. in Chemistry *5-10 years of relevant experience in regulatory affairs *Strong problem solving skills *Interpersonal and people skills *Planning, organizing and project management skills *Employee training and development skills *Oral and written communication skills **If you\u2019d like to hear more about this opportunity and others we are currently working on, please contact Steve Sapita at 815.756.1221 \/ [Click Here To Join]. JO: 559.17
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