Regulatory Affairs Consultant
4 weeks ago
The Lead/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, BRDD 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:
- Driving product submissions to Health Canada is required
- Lead and author major submissions to Health Canada like NDS, SNDS, ANDS, DMFs, etc.
- Author and review Module 1, 2 and 3 sections including CMC summaries
- Perform eCTD Publishing for major submissions to Health Canada like NDS, SNDS, ANDS, DMFs, etc.
- Lead Health Canada Pre-Submission meetings and negotiate/interact with Health Canada
- Lead Product Lifecycle Management for Division 1 and 8 drugs
- Assessing and managing post-market product changes along with product lifecycle
- Experience with drug development process for both generic and brand products
- Respond to clarifications from Health Canada within the 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 against regulatory requirements
- Developing and maintaining excellent working relations with Health Canada, Provincial Regulatory Bodies as well as Industry Association taskforces
Knowledge and experience in the following is preferred:
- Compile and manage Drug Establishment License, Medical Device Establishment Licence and Site License
- Review and working knowledge of Pharma Promotional Review against PAAB guidelines
- Knowledge of cosmetic regulations
- Pharmacovigilance experience
- Experience with Clinical/Non-Clinical study review and authoring summaries
- Health Canada Class III and IV Medical Device Applications
- Structured Product Labelling (SPL) working experience
You will be reporting to the Manager, Regulatory Services. 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. RAC Designation preferred.
Benefits
If you're a Regulatory professional in the Pharmaceutical industry, we have the environment and exposure to the type of work you want to do.
Q&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.
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