- Manage the regulatory department and contract projects- Interact directly with regulatory agencies and serve as point of contact- Develop, document and implement regulatory strategies for new regulations, standards, policies, and guidance issued by relevant regulatory authorities- Author, review, and coordinate regulatory submissions to the FDA (establishment registration, self-identification, ANDA, IND, 510k, user fees, amendments, annual reports, etc.)- Publish and validate eCTD submission files- Provide project management and customer service to contract clients - Serve as US Agent for international clients- Archive and maintain regulatory files- Provide regulatory review, feedback and/or approval for relevant documents- Write and review company SOPs- Create invoices and bill clients- Ensure company is in compliance with state and federal regulatory requirements- Collaborate with other company departments in support of regulatory submissions- Conduct company-wide training sessions as needed

- Reviewed, formatted, and assembled ANDA submissions.- Prepared establishment registration, SPL labeling, manufacturing license, SBIR application, trademark.- Developed new SOPs, internal procedures, and training materials and trained applicable personnel.- Maintained internal document control system for SOPs, batch records, specifications, inventory, etc.- Research and keep up-to-date on applicable patents, new regulation, guidance, BE and other submission requirements or request information from FDA.- Performed various QA functions – inventory management, in-process production sampling, shipping clinical trial material, safety training, OSHA and DOL requirements

- Post-production content editing with FinalCut Pro of lectures and special events for webcasts and podcasts to be posted on school website/Youtube.- Worked alongside clients to cater to specific media needs.- Controlled lighting, sound, and camera work for large lecture halls during class.- Assisted professors and campus groups to troubleshoot equipment issues.