Pharmaceutical Regulatory Affair
All aspects of the pharmaceutical industry related to products, processes, documentation, service delivery, research or testing procedures, manufacturing and packaging are guarded by regulations. The legislations are carved to pave the safest path for streamlined journey of the products from the company to the consumers in the market. These rules, guidelines and regulations are important for customer safety and necessary to be complied. The government intends to monitor companies responsible for discovery, research, testing and marketing of manufactured products to ensure safe supply which further contributes to public health welfare. Regulatory affairs originated to control the efficacy and safety of products in areas of medical devices, pharmaceuticals, veterinary medicines, cosmetics, agrochemicals, pesticides and complementary medicines for the purpose of public health protection. The department of regulatory affairs participates in development of product marketing concepts; approves packaging and commercial advertisements before use; provides strategic advice on extremely difficult decisions throughout the life of a drug.
Regulatory affair is critical for healthcare organizations or agencies to link different departments in the company. Regulatory professionals collaborate with authorities and different departments in order to meet regulatory commitments of the health authorities. Regulatory professionals are responsible for tracking the ever-changing legislation for distribution of the products in all regions; advising on legal matters, scientific restraints and requirements; collecting, collating and evaluating scientific data; giving strategic and technical advice; presenting registration documents to concerned regulatory authorities; carrying out negotiations necessary to obtain authorisation or maintain product availability in the market; making important commercial and scientific contribution to the success of a development programme; preventing problems caused by inappropriate scientific thinking, poor presentation of data or badly kept records. A myriad of scientific knowledge is needed among the professionals to expand into the wide realms of the pharmaceutical world.
Career In Pharmaceutical Regulatory Affair
A new class of professionals have emerged to handle regulatory matters for major multinational pharmaceutical corporations or small biotechnology companies in India.
Regulatory Affairs is an attractive career choice for students with multi-tasking, communication and teamwork skills. The industry needs regulatory affairs experts to cope up with timely delivery of large number of regulations. Highly regarded profession of regulatory affairs can be rewarding and intellectually stimulating within the industry. Well-trained regulatory affair professionals have to be updated with knowledge of all guidelines and regulations; trained in the practice to review regulation compliance and audit check; accomplished in appropriate documentation of various activities conducted at a food processing unit, manufacturing plant, biotechnology laboratory or any other organization or unit of the healthcare industry. These industries are employing trained workforce to assist in marketing approval, licensing and certification required for domestic sale, import and export of medical product.
The regulatory professionals are recruited as managers, specialists or associates in wide range of pharma, medical device, biotechnology, nutraceutical and cosmetic companies.
A regulatory specialist maintains expert-level knowledge of policies to support research and development; assess company protocols; prepare documents and manage projects. Regulatory scientists develop new tools, approaches and standards to evaluate the safety, efficacy, quality and performance of medical products for better benefit-risk assessment and facilitation of transparent and sound regulatory decision-making. Regulatory affairs managers are responsible for developing strategies to ensure regulation compliance within the organization.
∙ Pharmaceuticals
∙ Medical devices
∙ In vitro diagnostics
∙ Biologics and biotechnology
∙ Nutritional Products
∙ Cosmetics Pharmaceuticals
∙ Medical devices
∙ In vitro diagnostics
∙ Biologics and biotechnology
∙ Nutritional Products
∙ Cosmetics Pharmaceuticals
∙ Medical devices
∙ In vitro diagnostics
∙ Biologics and biotechnology
∙ Nutritional Products
∙ Cosmetics
Online Course in Pharmaceutical Regulatory Affairs
James Lind Institute (JLI) provides online program – Professional Diploma in Pharmaceutical Regulatory Affairs and Advance PG Diploma in Pharmacovigilance & Regulatory affairs for better job opportunities in Indian pharmaceutical industry.
For more information please visit: www.jli.edu.in