A pharmaceutical regulatory affairs and quality operations associate makes sure that medical devices and pharmaceuticals are tested and are ready for distribution.
A pharmaceutical regulatory affairs and quality operations associate makes sure that medical devices and pharmaceuticals are tested and are ready for distribution. You follow regulatory standards in Canada and any country where you export your product. You may work for a pharmaceutical company or for a governmental or non-governmental agency. You may also be called a Regulatory Affairs Specialist.
Generally, pharmaceutical regulatory affairs and quality operations associates:
- Design and execute clinical trials with quality control.
- Assess products under strict guidelines and keep proper documentation.
- Track and maintain regulatory correspondence and submissions.
- Use different strategies to meet changing regulations.
- Review and observe worldwide quality control guidelines.
- Audit tracking programs.
- Report and document when there are problems with medical devices or products.
- Provide good manufacturing practice (GMP).
- Communicate effectively with managers and people at regulatory bodies.
- Do technical writing and data entry.
- Make sure that the product you represent is safe, meets all standards and is ready for market.
This job requires:
College or University
This job requires
2 - 5
years of work experience.
As a pharmaceutical regulatory affairs and quality operations associate, you need to:
- Speak, write and read English.
- Be able to recognize and solve problems.
- Have attention to detail and be well-organized.
- Use word processing, spreadsheet, database, and email software.
You need to communicate in person, on the phone and in writing with governing and regulatory body personnel and co-workers. You need to use specialized terminology.
Since Canadian products are distributed worldwide, it can be helpful to know 2 or more languages.
Labour Market Information
Now, employers are looking for people who have a good understanding of foreign market practices and can speak 2 or more languages. Industry experience is also important. There are opportunities to advance to management-level positions.
The work prospects for this job are:
The average hourly wage for this job is: Not Available
These links will give you a list of related educational programs or where you can search for them. There may be other schools that have similar programs, such as private career colleges. You may be able to get advanced standing.
Here is a list of some bridging programs. These programs can help you assess your education and skills, get practical training or improve your language skills so that you can work in your field.
Here is a list of some language training programs, such as Enhanced Language Training (ELT) and Occupation Specific Language Training (OSLT).
Work Experience Programs
Many college programs and bridging programs in this field include co-operative (co-op) work experience.
Voluntary Membership Opportunities
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