Pharmaceutical Regulatory Affairs and Quality Operations Associate

A pharmaceutical regulatory affairs and quality operations associate makes sure that medical devices and pharmaceuticals are tested and are ready for distribution.

NOC Code: N/A

Job Duties

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.

Source: Pharmaceutical.ca

Job Requirements

Education

This job requires: College or University

Comparison with other jobs in this profession
JobLevel of Education Required
Pharmacy AssistantHigh School
Medical Research AssociatePost-Graduate
Pharmaceutical Regulatory Affairs and Quality Operations AssociateCollege or University
Technical Sales SpecialistCollege or University

Experience

This job requires 2 - 5 years of work experience.

Comparison with other jobs in this profession
JobYears of Work Experience Required
Pharmacy Assistant0 - 2
Medical Research Associate2 - 5
Pharmaceutical Regulatory Affairs and Quality Operations Associate2 - 5
Technical Sales Specialist2 - 5

Essential Skills

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.
  • Broad knowledge of mathematics, physics, chemistry and biology.
  • Basic understanding of Canadian regulations.
  • Expertise in laboratory analysis, manufacturing procedures and clinical testing. 

Source: Pharmaceutical.ca

Language Skills

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

Trends

Industry experience is important. There are opportunities to advance to management-level positions. Presently, there is a demand in medical device companies.

Source: Pharmaceutical.ca

Prospects

The work prospects for this job are: Not Available

Comparison with other jobs in this profession
JobWork Prospects
Pharmacy AssistantGood
Medical Research AssociateFair
Pharmaceutical Regulatory Affairs and Quality Operations AssociateNo Data
Technical Sales SpecialistFair

Wages

The average hourly wage for this job is: Not Available

Comparison with other jobs in this profession
JobAverage Wage/Hour
Pharmacy Assistant$17.00
Medical Research Associate$33.00
Pharmaceutical Regulatory Affairs and Quality Operations Associate$0.00
Technical Sales Specialist$25.00

Retraining

Educational Programs

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.

Bridging Programs

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.

Language Training

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

Helpful Links

The data in this profile is provided for informational purposes only. Some of the information may have changed since this profile was written. Please check the source for the most up-to-date information.