Most commonly reported 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 Persons Outside Organisation Communicating with people outside the organisation, representing the organisation to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.
• Interacting With Computers Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
• Making Decisions and Solving Problems Analysing information and evaluating results to choose the best solution and solve problems.
• Interpreting the Meaning of Information for Others Translating or explaining what information means and how it can be used.
• Updating and Using Relevant Knowledge Keeping up-to-date technically and applying new knowledge to your job.
• Establishing and Maintaining Interpersonal Relationships Developing constructive and cooperative working relationships with others, and maintaining them over time.
• Analysing Data or Information Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.

The Work

The work of a Regulatory Affairs Officer is to ensure the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products in order to control the safety and efficacy of products.

The role involves combining their knowledge of scientific, legal and business issues to ensure products, which are developed, manufactured or distributed by a wide range of companies, meet required legislation.

They advise on and coordinate the approval and registration of pharmaceuticals, veterinary medicines, complementary medicines, agrochemicals, pesticides, therapeutic devices, cosmetics and other products.

Regulatory affairs officers are the crucial link between their company, its products and regulatory authorities such as the Health Products Regulatory Authority (formerly the Irish Medicines Board) and the European Medicines Agency (EMA).

It takes up to 15 years to develop and launch a new pharmaceutical product. The Regulatory Affairs Officer will be involved from the beginning and throughout the process.

This is a desk-based role, involving the close study of scientific and legal documents. It typically requires working closely with scientific and medical personnel on a project or team basis.

Typical work activities include:

• Ensuring the company's products comply with the regulations
• Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to
• Collecting, collating and evaluating scientific data that has been researched by colleagues;
• Developing and writing clear arguments and explanations for new product licences and licence renewals
• Preparing submissions of licence variations and renewals to strict deadlines
• Monitoring and setting timelines for licence variations and renewal approvals
• Working with specialist computer software and resources
• Writing clear, accessible product labels and patient information leaflets
• Planning and developing product trials and interpreting trial data
• Advising scientists and manufacturers on regulatory requirements
• Providing strategic advice to senior management throughout the development of a new product
• Project managing teams of colleagues involved with the development of new products
• Undertaking and managing regulatory inspections
• Reviewing company practices and providing advice on changes to systems
• Liaising with, and making presentations to, regulatory authorities
• Negotiating with regulatory authorities for marketing authorisation
• Specifying storage, labelling and packaging requirements

Most commonly reported Work 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.
• 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.

This occupation is typically suited for people with the following Career Interests:

Investigative

The Investigative person will usually find a particular area of science to be of interest. They are inclined toward intellectual and analytical activities and enjoy observation and theory. They may prefer thought to action, and enjoy the challenge of solving problems with sophiscticated technology. These types prefer mentally stimulating environments and often pay close attention to developments in their chosen field.

Enterprising

Enterprising people like situations that involve using resources for personal or corporate economic gain. Such people may have an opportunistic frame of mind, and are drawn to commerce, trade and making deals. Some pursue sales and marketing occupations. Many will eventually end up owning their own business, or in management roles in larger organisations. They tend to be very goal-oriented and work best when focused on a target. Some have an entrepreneurial inclination.

Administrative

Administrative people are interested in work that offers security and a sense of being part of a larger process. They may be at their most productive under supervisors who give clear guidelines and while performing routine tasks in a methodical and reliable way.

They tend to enjoy clerical and most forms of office work, where they perform essential administrative duties. They often form the backbone of large and small organisations alike. They may enjoy being in charge of office filing systems, and using computers and other office equipment to keep things running smoothly. They usually like routine work hours and prefer comfortable indoor workplaces.

Relevant degree areas include life, physical, mathematical, applied and medical sciences. Training can also help you progress and there are both undergraduate and postgraduate courses in business and management which can support you in your career.

Training & Development Pathways

FET Centre Traineeship: Lab Assistant, Quality Management (Quality Assurance) available around Ireland at NFQ Levels 5-6 Search FET Courses

FET PLC Courses: Applied Laboratory Science, Applied Science - Forensics, Applied Science/Laboratory Techniques, Applied Science - Pharmacy Studies, Forensics - Applied Science, Engineering Technology, Biotechnology at NFQ Levels 5-6 Search FET PLC Courses

Apprenticeship: Lab Tech, Lab Analyst, Lean Sigma management Apprenticeships NFQ levels 6-9 Search Apprenticeships

Higher Education CAO Entry: The life sciences, Pharmacy, Pharmacology, Biochemistry, Medicinal chemistry, Biomedical science, Chemical and physical sciences, Biotechnology at NFQ Levels 6-8 Search CAO courses

Postgraduate Study Options  Global Trade Compliance, Medical Technology Regulatory Affairs, Pharmaceutical Regulatory Affairs, Process Validation & Regulatory Affairs, Regulatory Affairs (Bio) Pharmacheuticals, Regulatory Affairs and Toxicology at NFQ level 9

Smart Futures

SFI Science foundation Ireland

Last Updated: October, 2023

Salary Range (thousands per year)* €35k - €70k

Salaries vary based on employer, location, experience, duties, and role.

Data Source(s):
Brightwater / Sigmar / CPL / Morgan McKinley / Azon

Last Updated: July, 2024

* The lower figures typically reflect starting salaries. Higher salaries are awarded to those with greater experience and responsibility. Positions in Dublin sometimes command higher salaries.

View Salary information from Indeed.ie
Note: data not aways available

This occupation has been identified as a Job in Demand by the most recent National Skills Bulletin.

This information has been derived from the Solas National Skills Bulletin (2023).

Employment grew strongly for this occupation between 2018 and 2021, although employment remained unchanged in the most recent time period. Almost three quarters were employed in industry. Despite the static employment levels in 2022, there was a significant increase in the number of employment permits issued between 2021 and 2022 (by 1,100), with the industrial sector accounting for half of the increase. Roles for which permits were issued included quality, process, and design engineers.

This occupation had the highest number of mentions of vacancies that were difficult to fill in the Recruitment Agency Survey, especially for quality control/assurance, compliance/regulatory and process engineering roles. Employers (through Skills for Growth and/or Spotlight on Skills) have cited roles in design engineering (with specific industry knowledge), quality control and production engineers as being difficult to fill. Demand continues to be strong for this occupation despite static employment levels and issues with recruiting suitably qualified/experienced candidates for these roles are likely to persist. 

• The Health Products Regulatory Authority

  • Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2
  • (01) 676 4971
  • [email protected]
  • Click Here