Senior Regulatory Affairs Specialist

SUMMARY:

The Senior Regulatory Affairs Specialist will serve as the primary contact for all regulatory compliance related inquiries specific to Sharp US Commercial.  Will lead communications and provide recommendations regarding regulatory compliance related priorities and strategies to Sharp’s leadership team. Manage 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.  Command a strong understanding of regulations and interpretations for application to situations related to client information.  Provide decisions and directions which, 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 Senior Regulatory Affairs Specialist position. Other duties may also be assigned.

• 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. 
• Possess a strong working knowledge and functional ability for developing and maintaining controlled documentation of departmental procedures in compliance with FDA GMPs.
• 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.
• In alignment with Sharp’s strategic business models, 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.
• 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.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Demonstrated knowledge and application of FDA cGMP/GCP regulations, ANSI/ISO/IEC/ASQC standards, and 21 CFR Part 11 in a manufacturing setting
• Strong ability to create clear and consistent documentation and communications. 
• Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non‐technical audience

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 accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Associate or bachelor’s degree is preferred with a minimum of five years of direct Regulatory Affairs experience.
• Experience in the pharmaceutical industry is required. 
• Outside certification of basic quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, etc.) is a plus.

Essential skills include:

• Exceptional documentation and communication skills
• Excellent organizational and planning skills
• In depth knowledge of FDA regulations related to facility registrations/licensure
• Ability to multi-task and meet timelines
• Must be tenacious and self-motivated
• Must be able to extrapolate client needs based on requests and work independently to fulfill them accurately and completely the first time.

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 accommodation 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 accommodation 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.