Senior Regulatory Affairs Specialist Job Description
The Role of Regulatory Specialists in Product Safety, Regulatory affairs specialist resumes, Entry-level and mid-level regulatory affairs associates in the health care sector and more about senior regulatory affairs specialist job. Get more data about senior regulatory affairs specialist job for your career planning.
The Role of Regulatory Specialists in Product Safety
Ensuring the safety of countless products that Americans use every day is an important role that the regulatory affairs industry plays. 25 cents of every dollar spent by Americans is spent on regulated products. Regulatory specialists are often used at various stages of the product development process to ensure compliance, from research and development through manufacturing, marketing, and final approval.
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Regulatory affairs specialist resumes
The ideal candidate for a regulatory affairs specialist position should have several important skills, such as the ability to work effectively in a demanding environment, and be able to communicate effectively. If you have worked in regulatory affairs before and need to make a new resume, it is important to include a professional experience section to highlight your duties. If you are a HR manager who needs to hire a regulatory affairs specialist in your organization, you will need to create and post a detailed description of the position to inform potential candidates.
Entry-level and mid-level regulatory affairs associates in the health care sector
Entry-level, mid-level and senior professionals working in the health care products industry are the most likely to use the title of "regulatory affairs associate", because they monitor federal, state and local government regulations. They help other employees in steering new products through government approval processes and watch their companies' internal procedures to make sure they conform to government directives. An entry-level regulatory affairs associate can be called a "Regulatory Associate," "Regulatory Associate I," or "Regulatory Affairs Specialist."
Entry-level regulatory affairs associates are expected to have bachelor's degrees in life science, clinical research studies or engineering. Entry-level regulatory associates are often tasked with coordinating and completing reports required by federal agencies, maintaining complex files and electronic document management systems, and working with project teams to obtain approval for company products. A regulatory affairs associate is also known as a regulatory affairs manager, director of regulatory affairs or a consultant.
It is possible for regulatory affairs associates to have master's degrees in engineering, life science, or clinical research. They may hold regulatory affairs certification from the Regulatory Affairs Professionals Society if they have a master's degree in regulatory affairs. Managing international regulatory issues for their companies, helping plan strategies to get products approved by the government, and engaging in post-marketing surveillance of products are some of the tasks mid-level associates can do.
A regulatory affairs associate may be called a "Senior Associate Regulatory Affairs," "Director of Regulatory Affairs," "Vice- President for Regulatory Affairs," or "Chief Regulatory Officer." Some associates have degrees. Many have degrees in engineering, life science, business administration, and clinical research studies.
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The Regulatory Manager for NxStage Medical, Inc./h3>
The incumbent will manage the regulatory process for NxStage Medical, Inc. products and provide regulatory input into key quality system processes. The incumbent may be in charge of regulatory staff.
Regulatory Expertise
A degree in any field of science is good for entry-level jobs in regulatory affairs. The theoretical knowledge on legislations governing medical products and the understanding of the technicality involved in regulatory submission would be an added advantage if you were to become an RA specialist. Health product sector and how drugs are being developed are some of the things that are expected of RA professionals.
Keeping up with regulatory changes and their implications on the drug development and authorization process is a part of regulatory affairs. The project team meeting is where the professionals need to be able to convert complex information in a comprehensible manner. You should be prepared to write and review documents that are hundreds of pages long.
Prepare to support due diligence reviews, review of protocols, reports, and all types of regulatory documentation with regards to quality, safety, and efficacy. While most regulatory documents are structured in a way that is easy to read, it still requires a certain amount of linguistic skills to combine subject matter knowledge and information from a spectrum of regulatory guidelines in order to come up with a document that is in line with legal requirements. Speaking clearly and persuasively.
The professional can sometimes function as a representative for both internal and external parties. Being an effective communicator can be used to establish relationship with regulatory authorities, marketing department, manufacturing sites and other technical functions. Familiarity in another language is often considered an asset.
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