What Is Regulatory Affairs?

1. What Is Regulatory Affairs (RA)? RA is an industry that oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use.RA department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. RA professionals are responsible for ensuring manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development. In the drug, medical device, and biologic product industries, these phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. In the food industries, regulatory professionals engage with products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle. These regulatory professionals play a critical role in the development and distribution of medical technological advancements and drugs, disease-free food, improving people’s health and welfare around the world. What’s the Job Outlook and Market Demand? As the RA discipline plays an integral role in medicine, global health, food safety, and medical innovation, it’s no surprise that the job market is growing. In 2016, the U.S. regulatory market experienced a 42 percent increase in job listings and the U.S. Bureau of Labor Statistics estimates the field will continue to grow at an average rate of eight percent until 2026. As new and developing industries become increasingly regulated, the demand for additional and specialized regulatory expertise will increase. BUT WHAT DO THESE PROFESSIONALS ACTUALLY DO ON A DAILY BASIS? RA officers act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation. RA specialists are expected to be extremely passionate regarding the safety and efficiency of drugs and medical devices in the health care industry. Their interest for the sector must be deeply grounded into their function. This role demands expertise in a few distinct areas to be able to become successful. The role includes gathering, evaluating, organizing, managing and collating information in a variety of formats/ ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (MHRA), different regulatory bodies such as theFood and Drug Administration (FDA or USFDA), Health Science Authority or HSA, the Singaporean regulatory agency, European Medicines Agency (EMA) etc.

2. Some major responsibilities of professionals working in regulatory affairs departments are: Formulating a drug development strategies Providing regulatory consultation Conducting gap analysis Developing product dossiers and their submission to applicable regulatory agencies Communicating with regulatory agencies Providing regulatory affairs related training to applicable team members and/or departments Regulatory Affairs Careers in Clinical Research Ever since the field of pharmaceutical drug development, manufacturing and marketing became regulated by regulatory agencies such as the US FDA, EMEA, MHRA etc, the area of Regulatory Affairs has opened up new opportunities of employment. The growth of the clinical research industry has pushed this demand for skilled regulatory affairs professionals even further. Regulatory Affairs careers in clinical research are very satisfying and exciting as the regulatory function is vital in making safe and effective healthcare products available worldwide. Roles and responsibilities of regulatory professionals often begin in the research and development phases for each product and continue throughout the product life cycle. Regulatory Affairs professionals keep themselves updated with global and local regulatory policies, procedures and trends. They also maintain understanding of scientific and technical background of healthcare products. How Much Do These RA Professionals Earn? An entry-level Regulatory Affairs Specialist with less than 1 year experience can expect to earn an average total compensation (includes tips, bonus, and overtime pay) of ₹307K. An early career Regulatory Affairs Specialist with 1-4 years of experience earns an average total compensation of ₹386K. A mid-career Regulatory Affairs Specialist with 5-9 years of experience earns an average total compensation of ₹615K. An experienced Regulatory Affairs Specialist with 10-19 years of experience earns an average total compensation of ₹808K.

3. About The Course And The Programme At Dysmech Clinical Services Pvt Ltd (DCS) For regulatory affairs careers in clinical research and in the pharmaceutical industry at large one can undergo Advanced and Diploma courses in Regulatory Affairs and Clinical Research courses in Pune. DCS offers 1 year Advanced and Post Graduate Diploma in Clinical Research and Regulatory Affairs. Anyone prefers to be in Clinical research industry and medical profession can undergo for this programme for detailed knowledge on the same. The main intent of the course is to develop clinical research and RA professionals who are equipped with the most relevant and up to date knowledge and skills. Clinical research and RA training programme is practically driven and centered on the tasks expected of a RA professional in the clinical research industry. In this RA training we provide you with the understanding of the global regulatory structure and acquire skills needed for regulatory strategic planning throughout the life cycle. About DCS DCS is an educational, training and soft skill development organization. It is the centre for skill and entrepreneurship development in clinical research industry offering excellent platform and knowledge to land into a good company or enterprise and can boost their growth opportunities by availing the benefits of our wide network and contacts across the companies and industries. Our company provides best and state of art facilities and knowledge sharing platforms which is an exception in the Industry.DCS offers specialized programs with industry exposure in international standards with Drug information Association (DIA) courses in Pune from experts and top professionals of the same industry itself having a rich experience and exposure on the technologies in the Clinical research industry. You can very well trust in our honest dealings. Join regulatory affair courses in Pune today. Contact Us Address : 425, Pride Purple Square, Kalewadi Chowk Aundh Ravet Road,Wakad Pune: 411057, Maharashtra Ph. No. : +91 89568 95738 Email ID: mail@dcsplm Website: www.dysmech.com