Regulatory Affairs Specialists

Drug Regulatory Affairs Specialist
Regulatory Affairs Analyst (RA Analyst)
Regulatory Affairs Associate (RA Associate)
Regulatory Affairs Consultant (RA Consultant)
Regulatory Affairs Specialist (RA Specialist)
Regulatory Affairs Strategist (RA Strategist)
Regulatory Engineer
Regulatory Services Consultant
Regulatory Specialist
Regulatory Submissions Associate

What is a Regulatory Affairs Specialist?

A Regulatory Affairs Specialist is a professional responsible for ensuring that companies comply with all of the regulations and laws pertaining to their business. This role is particularly vital in industries such as pharmaceuticals, biotechnology, medical devices, and food safety, where regulations can be complex and subject to frequent changes. Specialists are tasked with preparing and submitting documentation to regulatory agencies, including applications for new products, research protocols, and advertising materials. They also keep abreast of legislative developments and communicate these changes to their organizations to maintain compliance. By acting as a liaison between the company and regulatory bodies, Regulatory Affairs Specialists play a critical role in the product development process, ensuring that new products meet the necessary standards before reaching the market. Their expertise helps to safeguard public health while also protecting their companies from potential legal and financial repercussions associated with non-compliance.

Career Assessment
Career Assessment

Tasks

  • 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.

Technology Skills

  • Data base user interface and query software
    • Microsoft Access
    • Microsoft SQL Server
    • Structured query language SQL
    • Yardi software
  • Presentation software
    • Microsoft PowerPoint
  • Medical software
    • Healthcare common procedure coding system HCPCS
    • Medical procedure coding software
  • Accounting software
    • Fund accounting software
    • Tax software
  • Document management software
    • Adobe Acrobat
    • Atrion Intelligent Authoring

Tools Used

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.

  • 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.

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.

  • Critical Thinking

    Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions, or approaches to problems.

  • Judgment and Decision Making

    Considering the relative costs and benefits of potential actions to choose the most appropriate one.

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.

  • Oral Expression

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

  • Deductive Reasoning

    The ability to apply general rules to specific problems to produce answers that make sense.

Education

How much education does a new hire need to perform a job in this occupation?

  • Bachelor's degree
    80 %
  • Master's degree
    10 %
  • Post-baccalaureate certificate
    5 %

    Awarded for completion of an organized program of study; designed for people who have completed a Baccalaureate degree, but do not meet the requirements of academic degrees carrying the title of Master

Work Activities

  • Evaluating Information to Determine Compliance with Standards

    Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.

  • Getting Information

    Observing, receiving, and otherwise obtaining information from all relevant sources.

  • Communicating with Supervisors, Peers, or Subordinates

    Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

  • Communicating with People Outside the Organization

    Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.

  • Making Decisions and Solving Problems

    Analyzing information and evaluating results to choose the best solution and solve problems.

Detailed Work Activities

  • Coordinate regulatory documentation activities.
  • Obtain documentation to authorize activities.
  • Prepare regulatory or compliance documentation.
  • Evaluate applicable laws and regulations to determine impact on organizational activities.
  • Explain regulations, policies, or procedures.

Work Interests

  • Conventional

    Work involves following procedures and regulations to organize information or data, typically in a business setting. Conventional occupations are often associated with office work, accounting, mathematics/statistics, information technology, finance, or human resources.

  • Enterprising

    Work involves managing, negotiating, marketing, or selling, typically in a business setting, or leading or advising people in political and legal situations. Enterprising occupations are often associated with business initiatives, sales, marketing/advertising, finance, management/administration, professional advising, public speaking, politics, or law.

  • Investigative

    Work involves studying and researching non-living objects, living organisms, disease or other forms of impairment, or human behavior. Investigative occupations are often associated with physical, life, medical, or social sciences, and can be found in the fields of humanities, mathematics/statistics, information technology, or health care service.

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Job Outlook

Projected salary and job growth

$43790.0 - $123710.0

New job opportunities are likely in the future. : Average

Assessment

Related assessments and tests

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