Regulatory Affairs Specialist

8/28/20

Waterloo, IA 50701

1036

FullTimeRegular

REGULATORY AFFAIRS SPECIALIST

The Regulatory Affairs Specialist will be responsible writing, review and submitting regulatory submissions.

Job Responsibilities

  • 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 document and maintain all CCC regulatory filings with Health Authorities.
  • Serve as primary site liaison with Health Authorities concerning regulatory filings (i.e. issue LOA’s, responding to deficiency letters, requests for additional information).
  • Serve as a 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, coordinate responses to customer inquiries).
  • Obtain, maintain and manage site accreditation with foreign Health Authorities as Korean FDA, Indian FDA and PDMA (Japan).
  • Provide guidance and in-put to CCC 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.

Job Qualifications

  • Bachelor’s degree in a life sciences discipline, chemistry preferred
  • 7-10 years of relevant regulatory experience, preferrably in an API manufacturing environment
  • Excellent communication skills
  • Good project management skills required
  • Experience in a manufacturing environment a plus
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