Career stability and advancement is offered in the field of regulatory affairs to make a tangible difference in ensuring the safety and effectiveness of medical devices, pharmaceuticals, cosmetics, food and nutritional products available in the market.
Regulatory affairs career
Regulatory affairs is a profession developed with the desire to protect the public health as well as control safety and efficacy of products like pharmaceuticals, veterinary or complementary medicines, medical devices, cosmetics, pesticides and agrochemicals. The primary goal for a regulatory body is to protect the public by providing and enforcing adequate standards for the safety of public health created on the basis of a legal mandate or legislation. Companies responsible in discovery, development, testing, manufacture and marketing must also ensure that the safe products are supplied to the market which contributes to public health and welfare. Regulatory affairs department often takes part in the development of product marketing concepts and approving packaging or promotional material before commercial availability. The new class of professionals have emerged with expertise and experience to handle such regulatory matters.
Regulatory professionals are responsible for tracking ever-changing legislation in all the regions for distribution of the products; collecting, collating and evaluating scientific data; advising on legal and scientific restraints or requirements; submitting registration documents to regulatory agencies and negotiating the process of obtaining or maintaining marketing authorisation of concerned products; giving strategic and technical advice; making important commercial and scientific contributions; avoiding problems or issues caused by badly kept records, poor presentation of data or inappropriate scientific thinking. A regulatory expert monitors submission of healthcare products which includes any information documented or submitted to a regulatory agency for review, notification or request for response of additional information. Excellent analytical abilities and strong communication skills are required in order to utilize regulatory knowledge and ensure compliance; collaboration with colleagues and interfacing vendors, customers or sales representatives and successfully oversee regulatory initiatives.
Job opportunities in Regulatory Affairs
The role and duties of employed professionals depends on the position available in pharma, medical device or biotech companies and government regulatory bodies. Regulatory associates work with project teams to coordinate completed reports required by regulatory agencies, maintain complex files or electronic document management systems and obtain approvals for various products. Regulatory affair associate include senior, mid-level and entry-level professionals monitoring government regulations, legislation and laws that affect the products within the healthcare industry. They assist other team members in internal procedures to ensure conformation of government directives and steering new products through government approval processes. Regulatory affairs specialists focus on completing, filing submissions to the appropriate agencies and ensuring meeting all applicable regulations established for products and services. These specialists prepare, compile and coordinate internal regulatory documents and processes, internal audits or inspections, registrations or license renewals submitted to regulatory agencies.
Regulatory coordinators help in advance medical treatment by overseeing clinical trials and establishing legal based acceptance of novel methods. Their role requires strong observation skills in collecting data on the trial proceedings and charting outcomes. Regulatory affairs officers ensure that pharmaceuticals, cosmetics products and veterinary medicines meet legislative requirements along with key duties of studying scientific and legal documents; gathering, organising, evaluating, managing and collating information in various formats. Regulatory pharmacists in private and public sectors act as the link between local regulatory authorities and the company on matters relating to the safety, quality and efficacy issues of drugs.
Online Regulatory Affairs Course at JLI
James Lind Institute (JLI) provides an online program – Advanced PG Diploma in Regulatory Affairs & Quality Assurance for better job opportunities in clinical research regulatory field.
For more information please visit: www.jli.edu.in