Featured Advice
What are your interests?

Linguistic?

Linguistic

The Linguistic's interests are usually focused on ideas and information exchange. They tend to like reading a lot, and enjoy discussion about what has been said. Some will want to write about their own ideas and may follow a path towards journalism, story writing or editing. Others will develop skills in other languages, perhaps finding work as a translator or interpreter. Most Linguistic types will enjoy the opportunity to teach or instruct people in a topic they are interested in.

Salary Range
€31k - €43k
Career Zone

In Brief...

Ensures the appropriate licensing, marketing and legal compliance of pharmaceutical and medical products.

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.
  • 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.

Skills

  • Reading Comprehension Understanding written sentences and paragraphs in work related documents.
  • Critical Thinking Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
  • Writing Communicating effectively in writing as appropriate for the needs of the audience.
  • Speaking Talking to others to convey information effectively.
  • 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.

In Summary - Regulatory Affairs Officer

Career Sectors

Regulatory Affairs Officers typically work in the following Career Sectors:

Drug Discovery and Development
Biological, Chemical & Pharmaceutical Science
Clinical Trials
Biological, Chemical & Pharmaceutical Science

Videos on the Web

The Work - Regulatory Affairs Officer

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, prepare, or review regulatory submissions for domestic or international projects.
  • Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • 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.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Prepare or maintain technical files as necessary to obtain and sustain product approval.
  • Coordinate efforts associated with the preparation of regulatory documents or submissions.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

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.
  • Updating and Using Relevant Knowledge Keeping up-to-date technically and applying new knowledge to your job.
  • Interacting With Computers Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.
  • Communicating with Supervisors, Peers, or Subordinates Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
  • Organizing, Planning, and Prioritizing Work Developing specific goals and plans to prioritize, organize, and accomplish your work.
  • Processing Information Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.
  • Interpreting the Meaning of Information for Others Translating or explaining what information means and how it can be used.
  • Establishing and Maintaining Interpersonal Relationships Developing constructive and cooperative working relationships with others, and maintaining them over time.
  • Making Decisions and Solving Problems Analyzing information and evaluating results to choose the best solution and solve problems.

Interests - Regulatory Affairs Officer

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.

Qualities

This role can be stressful because of the need to maintain high levels of accuracy, meet tight deadlines and negotiate successfully as an arbitrator.

To do the job well, personal qualities include:

  • Integrity
  • Attention to Detail
  • Dependability
  • Adaptability/Flexibility
  • Analytical Thinking
  • Stress Tolerance

Problem solving is a key skill - noticing a problem and figuring out the best or most efficient way to solve it.

Entry Requirements - Regulatory Affairs Officer

Relevant degree areas include life, physical, mathematical, applied and medical sciences in areas such as:

  • The life sciences
  • Pharmacy
  • Pharmacology
  • Biochemistry
  • Medicinal chemistry
  • Biomedical science
  • Chemical and physical sciences
  • Biotechnology

The College of Science, School of Natural Sciences at NUIG offer an MSc. in Medical Technology Regulatory Affairs.

Last Updated: August, 2015

Pay & Salary - Regulatory Affairs Officer

Salary Range (thousands per year)* €31k - €43k

Data Source(s):
Payscale.com

Last Updated: March, 2017

* 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.

Labour Market Updates - Regulatory Affairs Officer

Useful Contacts - Regulatory Affairs Officer

Career News

Future Opportunities in Irish BioPharmaChem Industry
Future Opportunities in Irish BioPharmaChem Industry
Posted by BioPharmachem Ireland
A Career in Engineering
A Career in Engineering
Posted by CareersPortal
Central Pharma to create 100 jobs in Kerry
Central Pharma to create 100 jobs in Kerry
Posted by CareersPortal
GMI to create 600 high-skilled jobs
GMI to create 600 high-skilled jobs
Posted by CareersPortal
Ireland a World Leader in BioPharma
Ireland a World Leader in BioPharma
Posted by CareersPortal
Why is Biology the most Popular Leaving Cert Optional Subject?
Why is Biology the most Popular Leaving Cert Optional Subject?
Posted by CareersPortal