Biotechnology and pharmaceutical firms rely on regulatory affairs managers to prepare government filings, interact with regulatory agencies and translate regulatory requirements into practical work instructions. The job is a demanding one, requiring a high degree of technical knowledge and people skills. You can enhance your effectiveness by focusing on key areas.
Familiarize yourself with the regulations applicable to your company's operations. The company relies on you to be the resident expert on product and process regulatory issues. It is important to understand not only the letter of the law, but also how it has been interpreted in similar situations or for similar products.
Learn your company's processes and products. The more you understand about the details of your company's operations, the better you can assess how rules will affect it, and provide guidance on how to comply. You also need to understand the scientific and technological background of the products and processes. Make sure you are involved in new-product development and in any planned changes to products.
Monitor regulatory changes. Subscribe to a regulatory update service or participate in conferences to keep abreast of new and proposed requirements. Look for trends and apprise company management of potential impact on your business.
Develop project-management skills. Developing and implementing regulatory compliance programs can be complicated. Learn how to manage complex objectives, milestones, time-lines and resources.
Pay attention to details. Regulatory filings for new products and clinical studies are complex and lengthy, and every form must be completed correctly to avoid costly delays or rejections.
Develop excellent interpersonal and communication skills. You must be able to interact effectively with all levels of the organization. Frequently, your success hinges on your ability to persuade or influence others to take action. Much of the communication is done in writing, so it is essential to be able to create instructions that are clear and easy to follow. The job also often requires making informative and persuasive presentations to top management or regulatory agencies. Strong negotiation skills may be required when dealing with regulatory agencies.
Keep your cool. The work environment is fast-paced and constantly evolving. You may have to juggle multiple projects with tight deadlines, and you have to be able to work under pressure. Manage your stress by keeping fit, eating right, and getting enough sleep.
Consider being certified. The Regulatory Affairs Professional Society offers a Regulatory Affairs Certification program covering U.S. and international regulations. Preparatory seminars and materials cover the areas of pharmaceuticals, medical devices, and biotechnology policies and laws.
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Regulatory Affairs Professional Society
Johns Hopkins University: Regulatory Affairs Professional Development Programs