Regulatory affairs and Registration
Pharmaceutical Solutions Industry
Total years of experience :16 years, 8 Months
1. Participation in developing the drug product formula.
2. Participation in preparation pilot batches in coordinate with Production department, and follow up delivering the stability samples.
3. Follow up the analysis results to start preparing CTD files.
4. Follow Up availability of the DMS, CEP, GMP Documents for all Raw materials with Purchasing Department.
5. Preparation all SOPs and forms which relate with R&D
Department.
6. Preparation the CTD for new product s according toSFDA Guidelines.
7. Using special Software to convert the CTD to NeeS or eCTD.
8. Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
9. Maintain current knowledge of relevant regulations, including proposed and final rules.
10. Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
11. Provide responses to regulatory agencies regarding product information or issues.
12. Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
13. Direct the preparation and submission of regulatory agency applications, reports, or correspondence
1. Follow up all packaging materials tests
2. Release the accepted packaging materials
3. Follow up all packaging materials defects with Quality assurance and Purchasing Departments
4. Preparation the specification of new packaging materials.
5. Follow up and monitor all packaging proofs and approve it according to special requirements
6. Member in external audit team (second party), special on Packaging Materials Companies
1. Revise all SOPs, systems which relate QC Department.
2. Revise the specifications for all Raw materials and Packaging materials referring to pharmacopeias.
3. Follow up marketing requirements which relate with Finished Product Certificate of analysis.
4. Follow up and monitor all packaging proofs and approve it according to special requirements
5. Follow up the expiry date for all chemical reagents and Reference standard, coordinate with purchasing department to get Material safety data sheet for each reagent.
6. Follow up and preparation all Registration and re-registering Drug product Requirements in coordinaste with Regulatory affairs and export markets.
1. Preparation all documents which relates in internal audit (First party).
2. Coordinate and appoint the Audit time with all departments.
3. member in internal audit team
4. Record all comments and defects at close meeting.
5. Follow up all corrections at frame time
6. Close the Audit reports.
7. Member in external audit team (second party), special on Packaging Materials Companies.
8. Follow up change control report and give it No.
9. Follow up customer complaint reports and give it No.
10. Follow up all disposal reports.
11. Follow up all packaging defects with purchasing Department.
12. Qualify the supplier in coordinate with Quality Control and Purchasing departments.
13. Follow up availability of DMF and CEP which relate with raw materials.
70.3 جيد