The Senior Regulatory Affairs Specialist will lead communications and provide recommendations regarding regulatory compliance related priorities and strategies to Sharp’s leadership team. They will manage the tracking, preparation, and completion of all facility registrations/licensure and ensure regulatory filing support is provided to clientele.
Requirements
- Possess advanced understandings of local, Federal and state regulations and publications regarding drug, device, and drug-device combination products.
- Lead the program and team who maintains the database and/or tracking systems for local, state, federal and foreign registrations and licensure for all Sharp facilities (US and EU).
- Oversee team maintenance of all company compliance databases (i.e. FDA and DEA) to ensure information to and from the agency remains accurate and current.
- Support the Annual Product Quality Review (APQR) report program for all products packaged at Sharp facilities and review of final reports as required.
- Respond to all client product filing/submission inquiries (foreign and domestic) ensuring relevancy to Sharp’s business activity and facility locations (US or EU) and accuracy.
- Provide timely and accurate responses associated with foreign markets, such as Mexico, Canada, China, Taiwan, Korea, Japan and others, for Sharp and Client product licensing, manufacturing authorizations, and applicable regulations.
- Lead the planning, scheduling, preparation and issuance of compliance related documents/statements for customers (such as Federal and State Registration Certificates, GMP Statements, Debarment Letters, Apostiles/legalization coordination, and obtain the required legal signatures for foreign application submissions, and Establishment Inspection Reports.
- Liaise with Sharp Legal, when appropriate to reduce legal liability and risk of non-compliance.
- Responsible for ensuring protection of Sharp’s Confidential information (Personnel, Business/Ownership) to reduce business risk and maintain Sharp’s competitive market advantages.
- Assist with initiating and maintaining Sharp Drug Listings at the request of the client within the FDA Drug Listing database system.
- Assist with FDA and DEA regulatory inspections, as needed.
- Support DEA Related Activity (ARCOS Reporting, UN Reporting, Year End Reports, DEA Form 222, Procurement Quotas, Import/Export, Internal Batch Tracking/Accountability, and Destruction Coordination.
- Support knowledge transfer and training to departmental team specific to regulatory affairs requirements.
