Regulatory Affairs Specialist
Waterloo, IA 50701
REGULATORY AFFAIRS SPECIALIST
The Regulatory Affairs Specialist will be responsible writing, review and submitting regulatory submissions.
- 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.
- 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