As a professional working in pharmaceutical regulatory affairs, a day on the job is never dull. Pharmaceutical regulatory affairs specialists have a wide range of responsibilities – all revolving around the safety of the pharmaceutical products dispensed by their respective facilities. After completing your regulatory affairs training, you’ll possess strong knowledge of legislation, regulatory systems and practices, enabling you to successfully monitor the safe development and manufacturing of pharmaceutical products, including oral drugs, topical medicines, and more.
If you’re considering training for this career path, previewing a typical day on the job will help you make a more informed decision about your future and get excited about what’s to come. Here, we look at the day in the life of a Regulatory Affairs Specialist working at a pharmaceutical manufacturing facility.
Get Your Documents Organized for the Day
As a regulatory affairs specialist, your job might begin with an overview of the documents you need to review, write, or file to ensure accuracy and productivity throughout the day. Regulatory affairs specialists handle several different documents, including:
- Case files
- New compliance regulations
- Reports on new products
- Applications for marketing permission for products
- Compliance verification documents
- and more
Spending your mornings getting these papers in order and identifying which documents you’ll need throughout the day sets you up for success, ensuring that you have all the necessary information to complete your tasks.
Regulatory affairs specialists will get their documentation in order at the start of their day
Conduct Compliance Inspections
After getting your papers in order, it’s time to make the rounds within the facility, verifying regulatory compliance for several new pharmaceutical products currently being manufactured. You’ll consult with teams that have been working directly in the manufacturing and testing of the drug or product, obtaining critical information about:
- How the drug or treatment is performing
- The quality of the ingredients
- Correct adherence to the manufacturing process
Upon performing the inspection, you’ll determine whether regulations are being met using your knowledge of the Canadian Food and Drugs Act and other applicable global regulations.
Create Procedures for Upcoming Regulatory Affairs Projects
In the afternoon, you may draft procedures for recently-approved products. Pharmaceutical regulatory affairs specialists are responsible for developing detailed procedural strategies for manufacturing a new product. To ensure that a product can be safely distributed for public consumption, regulatory affairs specialists must create guidelines for the manufacturing and distribution process.
Pharmaceutical regulatory affairs pros set up procedures to ensure that drugs are manufactured in compliance with industry regulations
Regulatory affairs guidelines communicate the relevant legislation and policies which must be adhered to while the drug or treatment is in production, keeping the processes compliant while remaining efficient.
Meeting with a Health Canada Representative
On occasion, you will attend meetings with Health Canada representatives. These meetings serve as a chance to discuss:
- Changes in national regulations and standards
- Any issues or misunderstandings in terms of compliance
- Updates within the pharmaceutical industry
Once such meetings have ended, you’ll write up your notes into a report to pass on to company executives, keeping them informed on the latest regulatory news. The act of interpreting this information for your colleagues as a regulatory affairs specialist is known as “interpretive assistance.”
In the afternoon, you’ll have a meeting with a representative from a regulatory body
Wrap Up for the Day
Towards the end of the day, it’s important to take the opportunity to tie up any loose ends. Your checklist might include:
- Signing off on and submitting paperwork
- Completing drafts of any procedural documents
- Responding to emails you’ve received throughout the day
- Reviewing your schedule for tomorrow
Once these tasks are complete, it’s time to head home after a rewarding day of keeping pharmaceutical products safe for distribution.
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