What is Regulatory Affairs & Pharmacovigilance
What are Regulatory Affairs and Pharmacovigilance?
Innovation is rife in today's world, but there is a long path from concept to implementation.
Nearly every phase in the drug and medical devices’ lifecycle starting from R&D moving forward through clinical research to marketing is governed by regulations.
The development of new drugs, biologics, and medical devices is a long, complex, and expensive process. It is estimated that the development of a new drug can take up to 17 years and cost up to $2 billion dollars. So, the pharmaceutical industry is always under enormous pressure to reduce the time and cost to bring these products to the market.
The success of a pharmaceutical company depends increasingly on experts with experience in regulatory processes due to continuous updates in legislation, policies, as well as technologies.
When one considers the vast number of products regulated by the regulatory authorities, it is clear why professionals with expertise in Regulatory Affairs have perhaps never been more important.
You can work with a government organization to protect patients’ safety or assist companies in bringing compliant medical products to market—there are many options in the field of Regulatory Affairs.
What is Regulatory Affairs?
Regulatory Affairs is the science responsible for applying the standards and regulations that assess the safety, efficacy, quality, and performance of the regulated medical products in order to get regulatory authorities’ approvals. Regulatory affairs is the link and the “go-between” the pharmaceutical or medical device company and the regulatory authority that regulate them like the U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), or any equivalent authority.
The biomedical industry needs regulatory affairs specialists to help engineers and scientists meet the regulatory authorities’ standards as they develop new drugs, medical devices, and biologics.
What is Pharmacovigilance?
Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It involves monitoring the safety of pharmaceutical products pre- and post-marketing to ensure their continued safe use. Pharmacovigilance aims to identify and evaluate adverse drug reactions, assess the risks and benefits of medications, and take appropriate regulatory actions to protect public health. It plays a crucial role in maintaining the safety and efficacy of medicines throughout their lifecycle.
What Do Regulatory Affairs Specialists Do?
Regulatory Affairs Specialists often work in a dynamic and demanding environment, where they must manage strict timelines and protocols. They need to be adept at working with databases and other information management tools, have excellent organizational, analytical, project management, and communication skills, and be able to adapt quickly to changing regulations.
The primary responsibilities of a Regulatory Affairs Specialist include:
- Compliance with domestic or international regulatory agencies and inspectors.
- Maintaining a deep understanding of new and existing regulations that may impact their organization’s products.
- Standardizing business operations and establishing clear, documented protocols.
- Explaining regulations, procedures, and policies to all employees and stakeholders.
- Maintaining data and files for future reference, particularly in the event of an audit by a regulatory agency.
- Prepare or review regulatory submissions.
- Prepare, gather, and review raw documents, including reports, international standards, harmonized guidelines, and clinical protocols.
- Reviewing marketing, legal, and technical documentation to assess compliance.
- Recommending courses of remediation to help their company achieve the necessary levels of compliance.
What are the Job Positions for the Regulatory Affairs Professional?
As of 2018, 73% of regulatory professionals are employed by a mix of academic institutions, clinical research organizations, regulatory authorities, or pharmaceuticals, medical devices, dietary supplements, and cosmetics industry.
Along with the promise of job security, pursuing a career in Regulatory Affairs affords a great deal of flexibility in where to choose to work. With so many options, regulatory affairs professionals can choose to work in organizations of any size, ranging from 10 to 10,000 employees in any of these departments and much more:
- Quality Control Department
- Clinical Research Department
- Regulatory Affairs Department
- Compliance Department
- Pharmacovigilance Department
Joining the Regulatory Affairs role is absolutely an option if you want to increase your salary or secure you a promotion. What Are the Expected Salaries for Regulatory Affairs Professionals?
Much like the setting and scope of a regulatory job, regulatory salaries vary, depending on job function, previous regulatory experience, seniority, geographic market, and highest earned degree. As market demand has increased, employers are willing to pay more for the right level of skill.
Since 1995, salaries across all Regulatory Affairs professionals have maintained a general upward trend, increasing by an average of 3.3% per year. 2016, the average yearly salary for regulatory professionals at all levels was $150,422.
In 2018, the Regulatory Affairs Professional Society (RAPS) reported that the national average total compensation for U.S.-based regulatory professionals by job level is:
- Vice President: $256,500
- Director: $189,000
- Manager: $139,000
- Project Manager: $128,000
- Specialist: $123,000
- Associate: $93,000
If you have a postgraduate certificate, your salary may substantially double depending on the industry you choose. Just remember that some fields will pay off more than others.
Also, if you’re looking to secure a promotion, RADEX Professional Training Programs can help you gain the knowledge and skills required to move up the ladder at your current company. Most companies prefer a postgraduate certificate to grant a promotion to management positions.