Position Overview
A regulatory affairs associate is usually hired by a pharmaceutical company, to ensure that all of its products (including drugs and equipment) meet legislative requirements.
They are required to perform a lot of research work, where they have to delve deep into the requirements of governing and compliance bodies, and then provide reporting support to the company.
Position Requirements
Usually, a bachelor’s degree in science is sufficient to work as a regulatory affairs associate. If you have had some experience in a similar field – even if the industry is not the same as where you intend to work now – there is a good chance of you being considered for the job.
To be considered eligible to work as a regulatory affairs associate, one has to possess great analytic abilities, along with exceptional skills in communicating with people from different walks of life.
Additionally, it is important to possess excellent time management and negotiation skills, as you might often find yourself in situations that require you to argue your case with a regulatory authority.
In addition to this, it is imperative for an individual working at this position to know the company’s products inside out so that he or she can effectively communicate this information to a regulatory authority.
While working as a regulatory affairs associate, you will be required to perform some or all of the duties listed below:
Sample Job Description for Regulatory Affairs Associate Resume
• Research new legislation, guidelines, and customer practices on a global level, especially of countries of export.
• Collect, organize, collate and evaluate scientific data that has been researched by dedicated specialists.
• Develop and write clear and concise explanations and arguments for both new licenses, and license renewals.
• Prepare submissions of license variations and renewals, ensuring that deadlines are strictly met.
• Monitor and set timelines for license variations and renewal approvals.
• Create clear and accessible product labels and patient information brochures, aimed at providing users with the required information.
• Provide advice and suggestions to scientists and manufacturers on regulatory requirements of different products.
• Plan, undertake, and oversee product trials and regulatory inspections, keeping updated with changes in legislation and guidelines.
• Outline requirements for labeling, storage, and packing, and ensure that organizations are made aware of them.
• Create and maintain effective liaison with regulatory authorities, to ensure that compliance issues are resolved effectively.
• Plan and develop product trials, interpret trial data, and ensure that correlating reports are created and submitted in a timely manner.