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Regulatory Compliance Specialist

2 months ago

Allentown, Pennsylvania, United States Sharp Corporation Full time


SUMMARY:

The primary responsibilities of this role include facilitating and communicating priorities and strategies related to regulatory compliance to Sharp Corporation's Leadership Teams. This position is tasked with coordinating the tracking, preparation, and completion of all necessary facility registrations and licensure at local, state, federal, and international levels. Additionally, it is essential to provide regulatory filing support to clients while ensuring compliance within Sharp's regulated environment. The role involves researching regulations and interpreting them for application to client-related situations. Inaccurate decisions or directions could potentially impact company compliance and client relationships.



ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following outlines the minimum responsibilities associated with the Regulatory Compliance Associate position. Additional duties may also be assigned.

1. Stay informed about local, federal, and state regulations and publications concerning drug and device products.


2. Maintain databases and tracking systems for all registrations and licensure for Sharp facilities, both domestically and internationally.

3. Ensure the accuracy and currency of all compliance databases (FDA, DEA) to maintain proper communication with regulatory agencies.


4. Support the Annual Product Quality Review (APQR) report program for all products packaged at Sharp facilities and conduct reviews of final reports as necessary.


5. Assess client product filing and submission inquiries (both foreign and domestic) for relevance to Sharp's business activities and facility locations.

Provide precise responses regarding Sharp and client product licensing, manufacturing authorizations, and local regulations.

6. Plan, schedule, prepare, and issue compliance-related documents and statements to external customers as required (including Federal and State Registration Certificates, GMP Statements, Debarment Letters, Apostilles/legalization coordination, obtaining necessary legal signatures for foreign application submissions, and Establishment Inspection Reports). Collaborate with Sharp's Legal team when appropriate.


7. Ensure the safekeeping and integrity of the Company Seal used in compliance-related documents and statements, including client product applications.

8. Safeguard Sharp's confidential information (Personnel, Business/Ownership) to ensure appropriate distribution in a legitimate and legal manner.


9. Assist in initiating and maintaining Sharp Drug Listings at the request of clients using the FDA Drug Listing database system.


10. Coordinate with Quality, Operations, Engineering, Warehousing, Project Management Teams, and Sales personnel to address FDA/DEA compliance activities across all sites, ensuring adherence to applicable regulations.

11. Assist with FDA and DEA regulatory inspections as necessary.

12. Support DEA-related activities (including ARCOS Reporting, UN Reporting, Year-End Reports, DEA Form 222, Procurement Quotas, Import/Export, Internal Batch Tracking/Accountability, and Destruction Coordination as needed).

13. Provide training to designated peers as requested by management.

14. Adhere to company procedures and policies.