In Summary - Regulatory Affairs Officer
Regulatory Affairs Officers typically work in the following Career Sectors:
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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:
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 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 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.
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:
- Attention to Detail
- 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
- Medicinal chemistry
- Biomedical science
- Chemical and physical sciences
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
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.