Pharmaceutical Career Paths

Regulatory Affairs

The number of career opportunities continues to grow in this field of pharmaceutical regulatory affairs. As regulatory processes increase in complexity and scope, and globalization occurs within the field, there will be continuing industry demand for people with a strong foundation in regulatory affairs. Rapidly expanding research and development efforts, and the need to increase speed to market, depend on the strategic involvement of competent regulatory affairs professionals. In addition, the experience will allow students to acquire specialized, hands-onskills within a specific industry.

Regulatory Affairs Graduates are successful at:

Regulatory Affairs Administrator
This role will play a vital part in supporting regulatory compliant strategies for business development, while working closely with the research and development and International sales teams. Your objective is to support the regulatory affairs activities to ensure corporate goals are achieved in a compliant organized manner.

Regulatory Affairs Associate
Your primary responsibility is to assist in the development of procedures and processes to ensure compliance with the Food and Drugs Act and Regulations, applicable provincial regulations and other applicable industry codes. The Regulatory Affairs Associate also interacts with relevant departments as well as external partners to ensure products are submitted, approved and launched in a timely manner.

Regulatory Affairs Manager
You will be responsible for the overview, guidance of the preparation, review, issue resolution, filing management of regulatory submission.

Clinical Quality Control Associate
As a Clinical Quality Control Associate you will ensure all prepared study source documents and/or forms are in accordance to protocols SOP’s and regulations. You must observe clinical procedures during the studies and make sure that they are performed in accordance to GCP regulation (Ie. Screening procedures, subject entrance etc.).

Stability Control Coordinator
The primary function of this role will be to support the goals and objectives of the Quality Assurance department in the development and maintenance of the companies stability program which supports the shelf life of there client’s products

Screening Clinical Data Reviewer
As a Data reviewer you will review and screen study files generated during subject selection for clinical trials

Regulatory Affairs Project Manager
As a Project Manager you will lead the development and implementation of regulatory strategic plans including regulatory strategy documents. You will prepare, submit and negotiate approvals of NDS, SNDS and NC’s

Regulatory Affair’s graduates are also successful in:

  • Medical Information Specialist
  • Quality Assurance Associate
  • Scientific Affairs Associate
  • Validation Consultant
  • Drug Safety Specialist