|Specific Duties and Responsibilities:|
This position manages Regulatory Affairs activities within Medefil, functioning as an independent and objective body that reviews and evaluates regulatory issues/concerns during the QbD product development process. Strong and proven QbD and CMC writing skills.
The position ensures the management and employees are in compliance with the rules and regulations of regulatory agencies and that company policies and standard operating procedures are appropriate and are being followed.
- Serve as the primary corporate liaison / contact with domestic regulatory agencies (e.g., FDA Investigators, Notified Body Auditors) regarding the Medefil�s quality management system.
- Complete CMC writing including QbD, Drug Substance, Drug product, and Labeling sections.
- Discuss and guide the project team to respond to the CRLs in timely fashion.
- Review and review product development reports.
- ISO Management Representative.
- Host FDA and ISO audits.
- Maintain, prepare, review, and implement Regulatory Affairs standard operating procedures.
- Prepare, review, implement and maintain quality manual, product technical files.( A plus)
- Review and monitor risk management process including post production risk.
- Review and approve implementation of the design history file and device master record.
- Manage the Customer Complaints Program: ( A plus)
- Medical Device Reports as appropriate to the FDA, Health Canada and the European Union. ( A plus)
- Post market surveillance monitoring, reports including product complaints and MDRs.
- Prepare and present to management tracking metrics for RA area activities, customer complaints/ MDRs.
- Manage the debarment list and MedWatch list review program.
- Manage product recalls and field removals.
- Manage; submit Licenses / Registration, and product listing to FDA
- Manage, control, review, and monitor product labeling and advertising materials for compliance with FDA labeling regulations.
- Other duties as necessary and as assigned
Education Minimum / Recommended:
- Bachelor�s Degree required.
- Some post graduate education with emphasis in Regulatory courses, business or law is a plus.
Work Experience Required:
- Five to Ten years proven experience in filing ANDAs, responding to the FDA deficiencies and obtaining the approvals.
- Person should have over five year experience in preparing and writing the complete ANDA dossier and publishing it in validated eCTD format.
- Experience in filing the ANDA submissions via Electronic Submission Gateway (ESG).
- Manage the establishment registration, drug listing, amendments, supplements, and annual reports over the life cycle of the product.
- Demonstrated experience of the aforementioned items along with accomplishment of 5 or more ANDA submissions to the US FDA and obtained approvals.
- Experience in multinational submissions and oncology products will certainly be a plus.