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Regulatory Affairs Specialists

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Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.

    Work Activities
    • Coordinate efforts associated with the preparation of regulatory documents or submissions.
    • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
    • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
    • Coordinate, prepare, or review regulatory submissions for domestic or international projects.
    • Prepare or maintain technical files as necessary to obtain and sustain product approval.
    • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
    • Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.
    • Coordinate recall or market withdrawal activities as necessary.
    • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
    • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.
    • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
    • Identify relevant guidance documents, international standards, or consensus standards.
    • Provide technical review of data or reports to be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
    • Review clinical protocols to ensure collection of data needed for regulatory submissions.
    • Provide pre-, ongoing, and post-inspection follow-up assistance to governmental inspectors.
    • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
    • Recommend changes to company procedures in response to changes in regulations or standards.
    • Participate in internal or external audits.
    • Compile and maintain regulatory documentation databases or systems.
    • Write or update standard operating procedures, work instructions, or policies.
    • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
    • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
    • Develop or track quality metrics.
    • Develop or conduct employee regulatory training.
    • Recommend adjudication of product complaints.
    • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
    • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
    • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
    • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
    • Determine the legal implications of the production, supply, or use of ozone-depleting substances or equipment containing such substances.
    • Monitor national or international legislation on ozone-depleting substances or global warming.
    • Obtain clearances for the use of recycled plastics in product packaging.
    Skills
    • Active Listening

      Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.

    • Speaking

      Talking to others to convey information effectively.

    • Writing

      Communicating effectively in writing as appropriate for the needs of the audience.

    WorkKeys®
    Applied Math
    5
    Workplace Documents
    5
    Graphic Literacy
    5
    Abilities
    • Written Comprehension

      The ability to read and understand information and ideas presented in writing.

    • Written Expression

      The ability to communicate information and ideas in writing so others will understand.

    • Oral Comprehension

      The ability to listen to and understand information and ideas presented through spoken words and sentences.

    Knowledge
    • English Language

      Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.

    • Law and Government

      Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.

    • Biology

      Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.

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    Pay
    • Ohio Annual Salary $61,990/yr
    • Typical Salary
    • Ohio Hourly Wage $29.80/hr
    • Typical Hourly Wage
    Ohio Employment Trends
    • Currently Employed 7,270
    • Yearly Projected Openings 650
    Typical Education
    Personality
    Conventional: People interested in this work like activities that include data, detail, and regular routines. They do well at jobs that need:
    • Attention to Detail
    • Integrity
    • Dependability
    • Cooperation
    • Analytical Thinking
    • Persistence
    Tools
    • Special purpose telephones
    • Scanners
    • Personal computers
    • Notebook computers
    • Desktop computers
    Technology
    • Project management software
    • Document management software
    • Data base user interface and query software
    • Business intelligence and data analysis software
    • Accounting software
    Tags
    • InDemand occupations are considered a priority by the state of Ohio.
    • Green occupations are jobs that contribute to energy conservation, development of alternative energy, reducing pollution, or recycling.