Associate Consultant - Regulatory
QC, Canada
Job Description
The Associate 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.
- NHP, OTC and medical device drug submissions interacting with health authorities
- Assessing post-marketed product changes
- Preparation of CoPP submissions
- Reviewed Food and NHP labels, claims, and nutrition fact panel
- Compiled Drug Establishment License (DEL), Site License (SL) applications and amendments, Category IV and Labeling Standard Drug Identification Number (DIN) submissions
- Responded to clarifications (Clarifax/IRN) from Health Canada within specified time frames
- Reporting to the VP Consulting Services, the Associate Consultant is responsible for:
- 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 product submissions
- 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.
- Prepare and ensure all submission documents are submission ready. This includes all formatting, bookmarking amp; hyperlinking
- Compile regulatory documents for submission to various Regulatory Authorities like HC amp; USFDA
- Perform validation of published eCTD and resolve all errors
- Regulatory/Quality support in OTC environment
Requirements
- A minimum of a Bachelor of Science degree is required, along with 1-3 years of relevant industry experience. FDA and/or EMA experience is a significant asset.
- Hands-on experience with electronic publishing systems for life cycle management of regulatory files for Health Canada
Benefits
Learn about what makes our company unique at www.qualityandcompliance.com. 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.