The regulatory affairs department of a pharma firm is responsible for getting approvals for new drugs or pharmaceutical products and making sure that the approval is maintained as long as the firm wants to keep the drug or any pharma product on the market. It serves as the interface between the project team and the authority.
It is the platform of communication with regulatory authorities as projects proceed, aiming to make sure that the plan correctly anticipates what the authority will need before approving products. Their responsibility is to keep up with current guidelines, legislation, and other intelligence. These guidelines and rules usually allow some flexibility.
Regulatory commissions expect firms to take responsibility for deciding how to interpret these things. These departments play a vital role in providing advice to project teams on how to interpret the rules the best way they can. During the development phase, sound working relations with agencies are very important when it comes to discussing issues such as divergence from guidelines, formulation development, and clinical research programs.
A lot of organizations prioritize and assess new projects depending on the intended TPP or Target Product Profile. The RA expert plays a very important role in advising on what will be the label or realistic prescribing information for the intended product. As a team member, the RA also contributes to helping design these development programs.
To know more about TPP, click here for more info.
These departments review every documentation from the regulatory perspective, making sure that it is consistent, complete, and clear, as well as its conclusions are pretty explicit. They also draft the prescribing information that’s the basis for approval. It will later provide the program for marketing.
These documentations include clinical trial applications and regulatory submissions for new drugs or products, as well as products subject to change and approval. The latter is a substantial task and will account for half of the work of regulatory affairs departments.
A vital proactive task of these departments is to provide resources when legislative changes are being proposed and discussed. There is an excellent possibility to apply influence at the early stages in the International Conference on Harmonization environment.
What are regulatory affairs?
As an authority, RA covers a wide range of specific occupations and skills. Under any circumstances, it is composed of individuals who act as a mediator between the possible conflicting worlds of governments, consumers, and industry to help ensure that marketed products are effective and safe when bought and used by customers as advertised.
Individuals who work in these departments negotiate interaction between the regulated or the industry, the market or the consumer, and the regulators or the government to get products to market and to keep them there while fending off wrong products from landing the shelves and being sold to consumers.
The variety of products covered by these people is pretty enormous, including agricultural and food products, medical devices and surgical equipment, veterinary goods, in vivo and in vitro diagnostic tests and tools, as well as medications that range from proteins to small molecules.
The range of problems addressed is substantial, like analytical and manufacturing testing, efficacy and preliminary testing, post-marketing follow-up, and clinical trials. With healthy doses of information management, project management, document preparation, issue negotiation, conflict resolution, and budgeting, advertising problems are all being covered.
Over the years, a complex system of checks and balances has been designed to set in place an excellent process to effectively and efficiently regulate the marketing of different products. On the industry side, individuals in this department work with clinicians, research scientists, marketing and sales groups, and manufacturing groups to ensure that governments have pieces of information they need to judge goods.
On the side of the regulators or the government, individuals in RA work to implement and interpret laws that Congress established to help protect the buying public. To carry out congressional mandates, the FDA or the Food and Drug Administration requires pharma firms to provide and generate all the necessary information to evaluate a given biological, device, or medication with respect to efficacy and safety.
Agencies use these pieces of information to decide whether the goods should be sold to the public, as well as how they should be sold and marketed. On the side of consumers, individuals with RA help keep the other groups honest. They provide the stimulus package for Congress to enact laws that regulate how industries and governments treat goods.
Check https://www.cfr.org/backgrounder/what-fdas-role-public-health to know more about the role of the FDA in our society.
Career opportunities in this industry
RA liaisons manage work processes with teams and interact with RAs, like the International Conference of Harmonization of Tech Requirement for Registration of Pharma for Human Use and the Food and Drug Administration. In addition to liaison positions, there are also other career opportunities available in this industry, such as submitting and managing regulatory information, publishing, and document management.
Posts in this industry offer good job security. The reason for this is supply and demand. Not enough individuals today have the right experience in RA, and the Food and Drug Administration has increased its standards. It requires more paperwork and supporting studies before goods can be approved for public use. To be successful in this industry, it helps to be processed-oriented and very detailed, as well as to possess excellent communication, interpersonal skills, and writing.
Drug research and strategy
RAs usually refer to groups of scientists who design strategies for interacting with regulatory agencies in different countries and the techniques of securing responses to address dealings with maintaining and submission of communication post-registrations. A lot of these scientists who populate RA groups were traditionally involved in the development or discovery of drugs to represent the science aspect to regulatory agencies accurately.
These professionals are also involved in the compilation of data in the form of investigations of new drug submissions or applications for final registrations. With today’s evolving landscape of regulatory guidance, these experts also need to remain world-class and state-of-the-art in what agencies are saying and thinking.
When it comes to the organization, these experts become involved when pre-clinical toxicology research is initiated on drug candidates. It usually represents the first event in designing information under GLP or Good Lab Practice. From this point on, RA is involved in almost all aspects of product development through the commercialization phase. The department is also involved in all post-commercialization activities.
For instance, activities that greatly involve expansions of data to modify current labels on marketed goods, submissions of new indications, or Pharmacovigilance or post-marketing surveillance and new formulations of safety are part of this industry. The RA also plays a vital role in designing medical device regulatory affairs training courses, reviewing advertising or other communications that are used to narrate new products before, during, and after a Non-Disclosure Agreement.
Diverse job opportunities in the life sciences and biotechnology industry
Liaisons manage processes for working with teams, as well as interacting with health agencies like the International Conference of Harmonization of Tech Requirements for Registration of Pharma for Human Use or the Food and Drug Administration.
Not only that, there are a lot of other job opportunities like submitting and managing regulatory info, publishing, and document management. There is a shortage of trained and skilled RA professionals. Because of this, RA experts are in demand. It offers good job security, and the pay is pretty good because of the talent shortage.
The biotech and Biopharma industry is segregated into different therapeutic areas; RA experts also need to specialize. It can take a couple of years to learn the ins and outs of these areas, like large and small molecules, neurosciences, oncology, new foods, molecular diagnostics, medical devices, gene and cell therapy, and infectious diseases.
Firms are desperate to hire personnel specializing in this industry and provide internships to fresh graduates and post-doctorate. They are also willing to train new recruits on the job. If a person is a detail-oriented professional, possesses good writing skills, as well as able to influence and manage a member of the team to write their sections, it is considered one of the most in-demand careers today.
