Senior Consultant - Regulatory

Senior Consultant - Regulatory
QC, Canada

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
Bachelor's Degree
Total Vacancies
1 Job
Posted on
May 6, 2021
Last Date
Jun 6, 2021
Location(s)

Job Description

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:

  • NDS, NHP, OHP and medical device drug submissions
  • Authoring of CTD Modules 1, 2, 3, 4 and 5 reports and risk management plans
  • Negotiating and interacting with health authorities
  • Assessing post-marketed product changes
  • Cannabis Act and regulation licensing
  • Compiled Drug Establishment License and Site License
  • Responded to clarifications from Health Canada within specified time frame
  • Establishing project plans that capture all aspects of the scope of work
  • Prioritizing and managing regulatory team projects
  • Completing critical assessments of data and documents to identify gaps compared to regulatory requirements
  • Driving the submission of Health Canada, FDA and EMA product submissions
  • Negotiation of product submissions with regulatory authorities
  • Provide regulatory guidance for Cannabis Act and regulation licensing for sites and products
  • Prepare Cannabis license applications
  • Liaise with Health Canada to obtain product and site licensing clarifications
  • Developing and maintaining excellent working relations with Health Canada, Provincial Regulatory Bodies as well as Industry Association taskforces

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.

Job Specification

Job Rewards and Benefits

QC

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