Career Story: Writer Of FDA Regulatory Submissions For A Pharmaceutical Company

Writer Of FDA Regulatory Submissions For A Pharmaceutical Company

Job Title: Pharmaceutical Chemistry Manufacturing And Controls Regulatory

Type of Company: My company is a pharmaceutical manufacturing and research company.

Education: BS, Chemistry

Previous Experience: I started as a laboratory chemist, testing pharmaceutical products, then moved into a role in R&D that encompasses regulatory submission writing, clinical supplies packaging and labeling and quality assurance. Then I moved into a position strictly doing regulatory affairs.

Job Tasks: I am responsible for the content of and writing of documents submitted to the FDA that describe how the active ingredient in a drug is chemically synthesized and tested, as well as how the drug substance is combined with inactive ingredients to make a tablet, capsule, cream, patch or injection. Information about how the drug is manufactured, packaged and tested is also described. These documents must be submitted to the FDA before a drug can be tested in humans (in a clinical trial) and before a prescription drug can be marketed. I also review the manufacturing records for quality assurance for any drugs that will be studied in humans as well as design processes and procedures to ensure product quality.

A typical day includes attendance at meetings discussing the drug projects being worked on. I also review data generated on drug products and look for unusual results or trends in the data over time to support that the drug product still meets appropriate specifications after storage for a certain amount of time (stability data). I help determine what specifications should be in place for the drug: what tests and what results are important to determine that the drug is of an appropriate quality for use in humans. Finally, I spend a great deal of time preparing documents and writing the information for submission to the FDA.

Best and Worst Parts of the Job: The best part of my job is taking a lot of bits of data and information and being able to put them into a single summary document that is easy for the FDA to review.

The worst part of my job is that all of the information I need comes from other people and it may come late, which means I have to rush to complete my job to meet a submission timeline.

Job Tips: There is little academic training for pharmaceutical Regulatory Affairs and basically no training specific to chemistry, manufacturing and controls regulatory affairs. A good basic scientific background is necessary: chemistry, biology, pharmacy. You will also need to start out in a basic research or laboratory area and move into regulatory affairs. It is not something you can start in without some related experience in the pharmaceutical industry.

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