Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs also has a very specific meaning within the healthcare industries (pharmaceuticals, medical devices, Biologics and functional foods). Most companies, whether they are major multinational pharmaceutical corporations or small, innovative biotechnology companies, have specialist departments of Regulatory Affairs professionals.
The success of regulatory strategy is less dependent on the regulations than on how they are interpreted, applied, and communicated within companies and to outside constituents. Regulatory Affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development and also after drug approval and marketing. The drug development process is a lengthy, complex and extremely costly albeit necessary process.
Pharmaceutical companies use all the data accumulated during discovery and development stages in order to register the drug and thus market the drug. Throughout the development stages, pharmaceutical companies have to abide by an array of strict rules and guidelines in order to ensure safety and efficacy of the drug in humans. In this highly regulated environment, regulatory affairs plays a critical role not only as the interface with health agencies and as a link between different departments in the company but also as the leading department to provide strategic advice on extremely difficult decisions through the life of a drug.
Regulatory professionals keep working with the authorities and different departments within the company in order to meet regulatory commitments with the health authorities. Regulatory Affairs also ensures the maintenance of the marketing licence and leads life cycle extension activities such as broadening the indication of the drug, change of formulation, changes in the dosage etc..
Regulatory Affairs is an attractive career choice for graduate students from a scientific background who enjoy communication and team work, are comfortable with multi-tasking and are eager to expand their knowledge in the wide realms of the Pharmaceutical world. Regulatory Affairs is a rewarding, intellectually stimulating and highly regarded profession within pharmaceutical companies.
Qualities of a good RA professional
- Team Player
- Good Communication Skill
- Analytical Skill- Ability to evaluate the strengths and weakness of the technical and legal options open to a company.
- Good Informational Technology skills
- Negotiating Skills
- Able to reapply scientific and regulatory principles
- Ability to work with other disciplines
- Flexible- Always willing to learn.
Responsibilities of Regulatory Affairs Department
- Keep in touch with international legislation, guidelines and customer practices
- Keep up to the date with a company’s product range
- Ensure that a company’s products comply with the current regulations.
- The Regulatory Affairs professional’s job is to keep track of the ever-changing legislation in all the regions in which the company wishes to distribute its products. They also advise on the legal and scientific restraints and requirements, and collect, collate, and evaluate the scientific data that their research and development colleagues are generating.
- Formulate regulatory strategy for all appropriate regulatory submissions for domestic, international and/or contract projects.
- Coordinate, prepare and review all appropriate documents for example dossier and submit them to regulatory authorities within a specified time frame in conjugation with the organization.
- Prepare and review of SOPs related to RA. Review of BMR, MFR, change control and other relevant documents.
- Monitor the progress of all registration submission.
- Maintain approved applications and the record of registration fees paid against submission of DMF’s and other documents.
- Respond to queries as they arise, and ensure that registration/ approvalare granted without delay.
- Impart training to R&D, Pilot plant, ADl and RA. Team members on current regulatory requirements.
- Advising their companies on the regulatory aspects and climate that would affect proposed activities. i.e. describing the “regulatory climate” around issues such as the promotion of prescription drugs and Sarbanes-Oxley compliance.
- Manage review audit reports and compliance, regulatory and customer inspections.
- Regulatory Affairs professionals help the company avoid problems caused by badly kept records, inappropriate scientific thinking or poor presentation of data. In most product areas where regulatory requirements are imposed, restrictions are also placed upon the claims which can be made for the product on labelling or in advertising.
- Have a duty to provide physicians and other healthcare professionals with accurate and complete information about the quality, safety and effectiveness of the product.
Major Regulatory Authorities
- India-Central Drugs Standard Control Organization drug controller general of India (DCGI)
- US-Food and Drug Administration (US FDA)
- UK-Medicines and Health care products regulatory Agency (MHRA)
- Australia-Therapeutic Goods Administration (TGA)
- Japan-Japanese Ministry of health, Labour and Welfare (MHLW)
- Canada-Health Canada
- Brazil-Agency Nacional degradation Vigilancia Sanitaria (ANVISA)
- South Africa-Medicines Contol Council (MCC)
- Europe-European Directorate for Quality of Medicines (EDQM),European Medicines Evaluation agencies (EMEA)