What are the responsibilities and job description for the Regulatory Compliance Associate position at Sharp Clinical Services?
SUMMARY:
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 designated peers at management request.
- Complies with company procedures and policies.
Decisions and directions provided, if not accurate, could affect company compliance and client engagement.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
SUPERVISORY RESPONSIBILITIES:
Moderate, including scheduling, oversight of assigned projects, and supporting Compliance Director as requested.
PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Associate or Bachelor’s degree is preferred with five years or more related experience. Experience in the pharmaceutical or related industry is required. Experience in Regulatory Affairs is a plus. Outside certification of basic quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, etc.) is a plus.
Good documentation and communication skills are required. Good organizational and planning skills are required. Knowledge of FDA regulations related to cGMPs is required. Knowledge of compliance is required. General knowledge of DEA regulations is required. Ability to multi-task is required.
- Excellent detail skills as they apply to documentation review and compliance.
- Excellent written and oral communication and interpersonal skills.
- Outgoing, assertive and reliable.
- Self-motivated and independent.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is normally required to sit at a desk or periodically go onto the shop floor. The working environment is clean and not normally subject to hazardous environment or conditions.
DISCLAIMER:
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.
