The term Regulatory Affairs in general refers to a framework or a platform formed by legislation and various bureaucratic institutions controlling the environment and conditions under which some products are developed, tested, manufactured and marketed. It is applicable to the areas of pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals and cosmetics. In terms of the medicines development, practically, it is all about the paperwork that must be done before you do anything in the area of new drug development and marketing. Of course, behind that paperwork there is a myriad of 'real things' like manufacturing processes and their quality assurance or clinical research during which patients are receiving an experimental treatment. At one day all information about the product, chemical properties, stability testing results, preclinical data from animals and in vitro tests, results from clinical studies and all related statistics, all these things must be put together in a specific format and submitted to some competent authority for Marketing Authorization. This process can be very long, involving many updates and it basically never ends because even after the initial registration the product dossier undergoes various changes like adding a new target population or indication, new labels, different shelf-life, packaging presentations and so on. While Marketing Authorizations Applications (MAA) are usually managed directly by the pharmaceutical company owning the product, Contract Research Organizations (CRO) mainly deal with pre-marketing activities. They help with development of strategies, preclinical data generation and clinical trial conduct.

All this may ring the bells of legal affairs and counselling but in fact it is just a matter of being ready to learn this stuff. There is no graduate program that could prepare you for this from the practical perspective, even though there are special Regulatory Affairs graduate programs offered by several universities, which can equip you with good theoretical grounds.

You will utilize your knowledge from chemistry and biology classes because it is a big advantage if you actually understand the content of the documentation. Your sound judgement and ability to think analytically and critically will allow you to contribute to the high quality of the dossier. This can seem boring but once you get deeper in the subject, you will find out that even bureaucratic pathways can be flexible if you are clever enough and you can save significant amounts of time and money on the way to get a new medicine to the people. On the other hand, you have to understand that regulatory institutions have to be both cautious and demanding to protect the society from products and practices potentially jeopardizing our quality of life or even safety. Executives of the pharma companies can be under high pressure to secure the reimbursement of what the company invested in the research. The roles under Regulatory Affairs encompass activities relating to preclinical and clinical research and marketing and manufacturing procedures and processes, as well as collection of  the safety and efficacy data when the product is already on the market.

But what practically you would be doing? At junior positions, after some learning, you will probably be completing documentation, application forms, submitting to and leading correspondence with drug agencies and ministries. Your internal company tasks will include filing, keeping trackers and updating databases. As you will grow in expertise your duties will be more and more related to development of strategies and leading projects and  teams or couching others. In CROs the work will be highly project specific and will involve some portion of the international team work and communication with clients.

Many job descriptions available on the internet are not accurate, are misleading or even incorrect. This is an attempt to describe very concretely what CRAs practically do. In this description we will completely disregard the academic research and will focus purely on the commercial sector.

In the typical clinical department this is almost an entry level position (a trainee CRA) but for many people CRA is their whole-life career because with increasing CRA experience they earn very good salaries, can work as independent contractors, usually have a good balance of travelling and office work and there is a high demand for them on the market. CRAs are real engines of clinical research.

Before registering a product as a medicine several stages of the clinical investigation must be done. They are called phase I, II and III. Some phases I involves the first administration to humans ever. A typical clinical study is conducted in multiple investigational centres (hospitals) in multiple countries. There are three main documents in every study: 1) Study Protocol, 2) Investigator's Brochure (IB) 3) Informed Consents Form (ICF).

The protocol is a kind of 'study cookbook' where the study design, timing, patient criteria, study objectives, endpoints, target populations and every procedure are captured. Investigators, contracted physicians and other personnel, cannot deviate from it. Like the protocol is a cookbook to the study, so the IB is a cookbook to the investigational / tested product. ICF is a key document where every patient signs off they enroll voluntarily and understand the study conditions. There are many more documents on the study, country and investigational site level though. Investigators on sites must be completing documentation correctly and in a timely manner.

The scope of the CRA activities varies from company to company. In small companies CRA can have many tasks going actually beyond the typical range of activities, like submissions of the study documents to Regulatory Authorities and Ethics Committees / Institutional Review Boards or assuming legal representation of the pharma company in a particular country. But usual working routine involves visiting the sites and checking if all activities are being performed according to the valid protocol and recorded appropriately. They can also explain unclear study details to the research staff as needed, on behalf of the study sponsor, which is typically a pharmaceutical company. Based on their 'monitoring visits' they compile periodic 'visit reports' and annual summaries for the sponsor. This activity dominates CRA's  work and it is called Clinical Monitoring. Quality of the clinical monitoring is of paramount importance to the validity of the conducted clinical research and the data collected. CRAs are main interface between the researchers and the pharma business. Sometimes they have office-based co-workers who process the related paperwork remotely in cooperation with them. These co-workers are sometimes called in-house CRA, Clinical Monitoring Associate (CMA) or similarly. As it can be difficult to get a CRA job as the first employment, CMA is an ideal starting position for those interested in becoming a CRA. Another suitable junior positions may be Start-up Associate, Site Activation or Site Coordination Officers etc.

All these position names could be generally designated with the term Study Startup Coordinator. The study means a clinical trial or study. The term site refers to a clinical research center like a hospital department or ambulance. These positions are more often open by CROs than by pharma and biotech firms. A typical junior start-up specialist coordinates study and site startup activities on the country level. Later also on  the regional, and project level,. Each site is led by a physician called Principal Investigator. The coordinators are in touch with these leads and are in charge of assembling of the documentation needed before the experiment can start. It includes contract management, preparation of patient-facing materials like ICF (Informed Consent Form) and collect necessary signatures in accordance with global regulations and country legislative requirements. They also closely cooperate with other functions like Clinical Research Associates, Project Managers and country or  project-specific Clinical Managers. This work includes administration of various IT systems used for tracking of the statuses of the documents and their storage (Trial Master File) and systems supporting site activation and trigger of the supplies of the investigational medicinal product (IMP) and other study materials to the investigational sites under the coordinator's responsibility.

The Pharmacovigilance (PV or PVG) Specialist assists with monitoring the safety, efficacy, quality and compliance of either marketed medicinal products or investigational medicinal products. Portfolio of activities under remit of the pharmacovigilance departments is very broad and complex and varies significantly depending on the company type. Pharmacovigilance is also one of the key roles of state regulators like national drug agencies or EMA's Pharmacovigilance Risk Assessment Committee (PRAC). The main purpose of this very robust international system is to collect data about Adverse Reactions associated with all medicines used in humans and timely detect any signal of possible risks and safety issues. The data are sytematically collected from clinical practice as well as development programs. The core of the data are cases of Adverse Reactions of various severity. The cases can be reported immediately, within a certain time frame or periodically via cumulative Safety Reports, as required. This job includes a lot of working with databases, creation of comments to and triage of the cases for evaluation by medical experts, their coding and direct reporting itself. Holding a medical degree is a great advantage and gives better chances for a good career in PV. Some special functions, for example PV Qualified Person, can be performed only by medical doctors.

Positions requiring knowledge of a clinical area are reserved for medical doctors with the respective certification or proven record in clinical practice.  Their expert input ranges from evaluation of safety events, through communication with physicians in clinical practice and providing them with guidance on the company products, to designing the development phases and pertinent documentation.

Surprisingly, this is not exclusively for graduates from medical colleges, even though a medical background is definitely a plus. However, it is necessary to have at least a scientific field background (Life Sciences, Biotechnology, Bio-engineering) and be experienced in reading and working with scientific papers and data mining. Responsibilities include scientific / clinical literature review of various diseases and their states, therapeutic advancements, current research trends and clinical data. Scope of the authored documentation contains monographs, presentations for medical professionals, texts for products leaflets, summaries for well recognized physicians cooperating with the drug developers (Key Opinion Leaders), to support a clinical research they can compile documentation like Investigator's Brochures or Study Protocols.

Again, this job typically does not require you to hold a medical degree. It is not even a typical education an MSL or MA has. Still in some cases it can be a must. A typical MSL holds PhD in Life Sciences. Responsibility at the entry level overlaps with Medical Writer at some points, like development or approval of scientific and marketing documents. But sometimes MSL sits much closer to Sales, providing them with advice and technical support. These people are usually in frequent contacts with KOLs (Key Opinion Leaders). They are assigned to a therapeutic area and provide up-to-date information on the products in relation to the advances in that area, attend and speak at congresses and organize educational events. This job usually involves a lot of travelling.

A specific manufacturing processes, product characteristics and testing must be defined to ensure consistent identity and safety of a product, throughout the production of  the multiple batches. The associated activities are called CMC. The proper analytical methods are validated specifically at each stage of the product life cycle, from the early development phases to the large commercial lots.  The evolution of CMC further includes continuous stability testing and requirements imposed on precise specifications and characterization as scaling-up proceeds (batch size increase) get stricter. After the preclinical phase and after clinical trials the scale up batches must be of the same identity and meet the same specifications as before.  This applies for all types of medicinal products; small molecules, biologics and advanced therapies like gene therapy products. However, all of them follow different  set of requirements, under the umbrella of GMP.

CMC specialists are often associated with Regulatory Affairs or Quality Assurance. They can be either of purely administrative nature, in which case you would be compiling data into a technical documentation in a required format. Type of the documentation and the format depends on the purpose and geographical location or 'jurisdiction'. If under the remit of Quality Assurance, you can be in physical contact with the actual manufacturing process, located in the manufacturing facility.