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Career Story: Regulatory Affairs Specialist For A Biotech Manufacturing Company

Regulatory Affairs Specialist For A Biotech Manufacturing Company

Job Title: Regulatory Affairs Professional

Type of Company: Biotechnology. We manufacture products to test for a bacterial toxin and a diagnostic product to help detect fungal infections.

Education: B.Sc., Zoology, University of Wales (UK) •• Ph.D., Marine Biology, University of Southampton (UK)

Previous Experience: I worked for an environmental consulting company and then as a research assistant at a university while working on my Ph.D. Before I got into Regulatory Affairs, I worked in manufacturing.

Job Tasks: My company is regulated by the government and my job is to make sure that we comply with the regulations. For new products or changes to existing products we have to inform the authorities of the changes we propose to make and support them with test data showing that the changes are safe and effective. I do not generate this information but I assemble the report we submit. When the government asks for more information on a change, it is my job to make sure that we supply it to them. I also review many company documents about our products and processes to make sure that we comply with our own procedures and regulations.

In addition to the above, I am often involved in discussions about technical issues affecting our products because of my background in manufacturing. I give presentations and courses on technical matters and the regulations that apply to our products and their use in industry. I travel several times a year to do this, sometimes in the USA and sometimes overseas.

Best and Worst Parts of the Job: One of the worst parts of my job is facing the many documents that have to be reviewed. However, once you get into them there is often an interesting story being told or a problem being addressed. So, as with many things, the anxiety beforehand is often worse than the actual job once you get started.

The best part of the job is the satisfaction of getting a new product or process approved so that we can manufacture something more efficiently or introduce a new product. I also enjoy teaching and the satisfaction of giving a good presentation, especially at meetings in interesting places.

Job Tips: Don't shy away from the hard courses, even if they are not your major area of interest. Math never goes amiss and statistics have a very broad application. A good grounding in chemistry is often helpful to a biologist too.

Additional Thoughts: Regulatory Affairs is a growing (and relatively new) profession. There is a shortage of people in the field, so there is good potential for growth. A background in Quality Systems is helpful.

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