SOUTH AFRICA · SALARY IN RANDS

Regulatory Affairs Specialists

What the work involves, the skills employers want, and how to get started in South Africa.

  • 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

What do Regulatory Affairs Specialists do?

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.

What the work actually is

  • 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.

Skills employers expect

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.

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.
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How people get into it

Education of new hires

Bachelor's degree
Master's degree
Post-baccalaureate certificate
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

A normal week

  • Evaluating Information to Determine Compliance with Standards
  • Getting Information
  • Communicating with Supervisors, Peers, or Subordinates
  • Communicating with People Outside the Organization
  • Making Decisions and Solving Problems

Tools used on the job

Technology

  • 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

  • Photocopiers Photocopying equipment
  • Scanners Computer data input scanners
  • Notebook computers Laptop computers
  • Special purpose telephones Multi-line telephone systems
  • Laser fax machine Laser facsimile machines

Who it suits

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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Questions people ask

How much do Regulatory Affairs Specialists earn in South Africa?

Regulatory Affairs Specialists salaries in South Africa vary by experience, province and employer.

What do Regulatory Affairs Specialists do?

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 and Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

How do I know if this career fits me?

Take the free Assessify career assessment. It matches your answers to careers and shows the South African salary next to each one.