Regulatory Compliance Associate

SUMMARY :

The major functions of this job : Communicate and facilitate regulatory compliance related priorities and strategies to Sharp’s Leadership Teams.

Coordinate the tracking, preparation, and completion of all facility registrations / licensure (local, state, federal and foreign).

Ensure regulatory filing support is provided to clientele and

maintain compliance in Sharp’s facilities regulated environment. Research regulations and interpret for application of situations related to client information.

Decisions and directions provided, if not accurate, could affect company compliance and client engagement.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

The following is a list of minimum responsibilities related to the Regulatory Compliance Associate position. Other duties may also be assigned.

Review and keep current with local, Federal and state regulations and publications regarding drug and or device products.

Maintain database and / or tracking systems for local, state, federal and foreign registrations and licensure for all Sharp facilities (US and EU).

Maintenance of all company compliance databases (FDA, DEA,) to ensure information to 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.

Review client product filing / submission inquiries (foreign or domestic) for relevancy to Sharp’s business activity and facility locations (US or EU).

Provide accurate responses associated with Sharp and Client product licensing, manufacturing authorizations, and local regulations.

Plan / schedule, prepare and issue compliance related documents / statements to external customers where needed (such as Federal and State Registration Certificates, GMP Statements, Debarment Letters, Apostiles / legalization coordination, obtain the required legal signatures for foreign application submissions, and Establishment Inspection Reports.

Liaise will Sharp Legal, when appropriate.

Responsible for the safe keeping and integrity of the Company Seal used where required in compliance related documents / statements, including client product applications (foreign & local).

Ensure Sharp’s Confidential information (Personnel, Business / Ownership, where needed to be shared externally is appropriately distributed in a legit / legal manner.

Assist with initiating and maintaining Sharp Drug Listings at the request of the client with the FDA Drug Listing database system.

Coordinate with the Quality, Operations, Engineering, Warehousing, Project Management Teams, and Sales personnel to address FDA / DEA compliance activities at all sites as well as compliance to regulations as applicable to work product.

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, Destruction Coordination as needed.

Responsible for training of designated peers at management request.

Complies with company procedures and policies.