Regulatory Specialist in Worthington, Minnesota at Prairie Holdings

SUMMARY

Ensure compliance via the coordination, preparation and review of regulatory documents, processes, and submissions to support animal health company,

ACCOUNTABILITIES

Reports to: Regulatory Director

Supervises: Has no Supervisory Responsibilities

Location: Cambridge Technologies Administration Building, Worthington, MN

ESSENTIAL DUTIES & RESPONSIBILITIES

Review biologics orders for compliance and accuracyInitiation, collection, and coordination of information of regulatory documents for various purposesCoordinate and review regulatory paperworkResolve regulatory issues and facilitate opportunities for improvement by problem solving and collaboration with colleaguesCreate and maintain databases of required regulatory information for tracking complianceAssist in internal audits records, including but not limited to licensed documents, distribution records, and production recordsOther duties as assigned

EXPERIENCE & EDUCATION

Minimum of a two-year degree in animal sciences, business, administration, or related field preferredA minimum of one (1) year experience in compliance, customer service, administrative assistance, business administration, or related field preferred

LANGUAGE SKILLS

Ability to read and interpret documents such as regulatory guidance documents and procedures. Ability to write routine correspondence.

MATHEMATICAL SKILLS

Ability to apply concepts of basic math.

REASONING ABILITY

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving variables in standardized situations.

OTHER SKILLS AND ABILITIES

Attention to detail. Communication skills - verbal and written. Data collection, management and analysis. Problem analysis and problem solving. Planning and Organizing. Judgement. Decision-making. Customer service orientation. Teamwork.

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.

The employee is frequently required to sit continually or almost continually; walk; sit; reach with hands and arms; stoop, kneel, crouch, or crawl and talk or hear.