The Senior Consultant--Regulatory role focuses on maximizing and protecting the commercial interests of our clients. Our consultants often work closely with marketing, quality assurance, project management and legal teams, so that drug development, filing of submissions and maintenance of product compliance activities are undertaken in a timely manner.
We are looking for consultants who want to apply their in-depth regulatory knowledge and out-of-the-box thinking to challenging projects with our clients. Our projects cover submissions to TPD, NNHPD, BGTD and MDB.
In this broad-based role, you will drive the registration of various products according to applicable regulations. The role specifically prioritizes, plans and organizes regulatory-related projects to ensure smooth implementations. The role may involve coordinating the work of several consultants.
Knowledge and experience in the following are required:
Reporting to the VP Quality Services, the Senior Consultant is responsible for:
You will also be required to maintain up-to-date knowledge of regional and national regulations, guidelines and advisory documents, along with advances in relevant scientific fields.
Requirements
A minimum of a Bachelor of Science degree is required, along with 5-8 years of relevant industry experience. FDA and/or EMA experience is a significant asset.
Benefits
If you're a Quality Assurance professional in the Pharmaceutical industry, we have the environment and exposure to the type of work you want to do.
Qamp;C welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.