Regulatory Affairs Manager

SUMMARY   Monitor compliance of facility, documentations, procedure and personnel to regulatory requirement through audit, training and documentation.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. Administration of Regulatory Affairs.
2. Review all regulatory agency materials and resources to guarantee accuracy, timeliness, comprehensiveness, and compliance with regulatory standards.
3. Update all applicable licenses and permits.
4. Conduct internal and external audits, documentation, and completion of corrective actions as scheduled.
5. Assist in preparing, updating, and implementing general SOPs and department related SOPs. Conducts employee orientation regarding SOPs, cGMPs, and safety policies.
6. Provide regulatory guidance to departments and ensure that information is interpreted correctly.
7. Oversee documentation efforts to ensure compliance with domestic and international regulations and standards. Prepare export documents and forms of importing countries as required by customers.
8. Respond to client complaints and queries on regulatory issues.
9. Provide responses to regulatory agencies regarding product information or issues.
10. Manage the processing validation protocol and product reporting.
11. Manage Deviation Reports and assist in handling Customer Requests, Customer Complaints, OOS, and Failure Investigations.
12. Review materials such as marketing literature and labeling to ensure that applicable regulatory standards are met.
13. Review formula and manufacturing procedure, ensuring accuracy and timely delivery.
14. Ensure accuracy and completeness of product dossier and master formula.
15. Create and issue quantitative formulas and ingredient listings.
16. Safety Data Sheets (SDS) authoring and issuance.
17. Issue Form Template numbers and maintain Technical Forms.
18. Collate and maintain technical documents for regulatory review and international compliance.
19. Plan for the accomplishment of goals in an efficient, timely and productive manner.
20. Maintain leadership by setting examples.
21. Keep informed of the latest regulatory developments affecting the company through publications, trade journals, seminars, and workshops.
22. Prepare reports on department activities.
23. Other duties assigned by R&D/Regulatory Director.

SUPERVISORY RESPONSIBILITIES Directly supervises the staff in the Regulatory Affairs Department for both California and Ohio locations