What is Regulatory Affairs?
Regulatory affair is a profession within regulated industries such as pharmaceuticals, biopharmaceuticals, medical devices, cosmetics and consumer health, natural health, and veterinary products.
A regulatory affair is a department within the company that interacts with the government authorities who regulate the activities of the company. Their aim is to protect public health in terms of safety, quality, and efficacy of products like medical devices, pharmaceuticals, veterinary medicines, pesticides, cosmetics & complementary medicines, agrochemicals, etc.
These professionals keep a check on how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed in order to ensure that the products being supplied are safer for public health-wise as well as in providing a profitable contribution to the welfare of the public.
Although regulatory affairs specialists work in a wide variety of disciplines such as public policy, health, science, economics, and law but the majority of them work in industries such as biotechnology, food science, pharmaceutical as well as medical device sectors. Few others work as consultants in marketing, research, or law entities in their Regulatory Affairs careers.
Some are also employed by healthcare, clinical research organizations, and hospitals as well as in academic settings and government agencies. Thus one can say that it’s a combination of science and management in order to achieve a commercially important goal within a drug development organization.
Regulatory Affairs Career is a profession within the healthcare industry namely, pharmaceutical, healthcare, medical device, biologics, and functional food. It forms a bridge between drug regulatory authority, the pharmaceutical industry, and regulatory affairs professionals. It is a centralized department for communication of registrations and queries associated with a product in FDA as well as the ministry of health of various countries.
The main objectives of the Regulatory Affairs Job Profile are:
- Keeping track of changing legislation in regions where the company distributes its products.
- Interpret and apply regulations.
- Advise internal colleagues on legal and scientific requirements.
- Develop and implement regulatory strategies.
- Collect, collate and evaluate scientific data.
- Participate in product development programs to ensure adherence to international regulations and guidelines.
- To give strategic and technical advice to R&D, production, QC department, etc right from the beginning of the development of the product, making an important contribution both commercially and scientifically to the success of a development program and a company as a whole.
- Prepare submissions to regulatory agencies such as Health Canada, EMA(Europe), and other jurisdictions.
- Helping the company in order to avoid problems that may be caused due to improper scientific thinking or due to poor presentation of data.
Regulatory Affairs professionals interact with numerous functional areas which include:
- Pre-clinical research: Pharmacology and toxicology testing to evaluate new drug candidates.
- Clinical Research: Conduct clinical studies, data collection, statistical analysis, and report writing
- Manufacturing: High levels of controls for the production of safe and efficacious products.
- Quality control: Analytical testing of all products in terms of purity, safety, potency, and quality.
- Quality assurance: Oversight of operations related to failure investigations, auditing, complaints, and documentation management.
Qualifications Required To Become A Regulatory Affairs Professional:
However, professionals with essential skills in biology, clinical sciences, management, engineering, and writing are also highly desired candidates for this diverse field.
A Bachelor’s degree in the field of science especially pharmacy, biology, pharmacology, microbiology, and biochemistry is a must for getting into an RA.
For junior positions, undergraduates or postgraduates is sufficient but for senior positions
In the field of clinical research, it is mandatory for a person to have a doctorate degree.
In order to get very good success in this field, one must start his/her career in a related field, for example, laboratory testing, production, quality control, quality assurance, etc. with this he/she will get a good practical experience in drug development and its related process.