Regulatory Affairs Specialists

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About the Job

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.

It is also Called

  • Research Quality Assurance Specialist
  • Research Quality Assurance Analyst
  • Research Compliance Specialist
  • Regulatory Submissions Associate
  • Regulatory Specialist
  • Regulatory Services Consultant
  • Regulatory Compliance Specialist
  • Regulatory Associate
  • Regulatory Analyst
  • Regulatory Affairs Strategy Specialist
View All

What They Do

  • Specialize in regulatory issues related to agriculture, such as the cultivation of green biotechnology crops or the post-market regulation of genetically altered crops.
  • Obtain clearances for the use of recycled plastics in product packaging.
  • Monitor national or international legislation on ozone-depleting substances or global warming.
  • Determine the effects of legal requirements related to the production, supply, or use of ozone-depleting substances or equipment containing such substances.
  • Determine requirements applying to treatment, storage, shipment, or disposal of potentially hazardous production-related waste.
  • Determine regulations or procedures related to the management, collection, reuse, recovery, or recycling of packaging waste.
  • Develop or track quality metrics.
  • Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
  • Coordinate recall or market withdrawal activities as necessary.
  • Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.

Interests

People who work in this occupation generally have the interest code: CE.

This means people who work in this occupation generally have Conventional interests, but also prefer Enterprising environments.

Work Values

People who work in this occupation generally prize Working Conditions, but also value Independence and Achievement in their jobs.

Things They Need to Know

  • 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.
  • Clerical - Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
  • Computers and Electronics - Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
  • Administration and Management - Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.

Things They Need to Be Able to Do

  • Reading Comprehension - Understanding written sentences and paragraphs in work related documents.
  • Writing - Communicating effectively in writing as appropriate for the needs of the audience.
  • Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
  • Speaking - Talking to others to convey information effectively.
  • Complex Problem Solving - Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
  • Judgment and Decision Making - Considering the relative costs and benefits of potential actions to choose the most appropriate one.
  • 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.

Education Required

Most of these occupations require a four-year bachelor's degree, but some do not.

Wages

In 2016, the average annual wage in Pennsylvania was $67,390 with most people making between $38,270 and $101,530

Outlook

0.39%
avg. annual growth

During 2014, this occupation employed approximately 10,990 people in Pennsylvania. It is projected that there will be 11,420 employed in 2024.

This occupation will have about 43 openings due to growth and about 157 replacement openings for approximately 200 total annual openings.



Pennsylvania Department of Education