About this role
- Ensures clear communication of project activities in a timely manner.
- Ensures submissions are completed, properly formatted and comply with applicable regulatory requirements and the company’s processes.
- Assist with verbal and written correspondence with local Health Authorities.
- Ensures timely and appropriate regulatory submission management for Medical Device License (MDL), Drug Establishment License (DEL), Medical Device Establishment License (MDEL), Drug Applications (including DINs NDSs, ANDSs) and associated annual renewals.
- Assess regulatory reporting requirements for new products and post approval product changes.
- Contribute to strategies to resolve potential regulatory issues.
- Contribute to the company’s expertise in Canadian Health Authority Guidances and Requirements.
- Prepare and maintain internal Regulatory and Quality processes and procedures.
- Support various internal projects involving Marketing Brochures, Product Labeling, Importation Process, Distribution Process, Product Development, Product Release, Purchased Finished Goods (PFGs), and Supply and Service Agreements.
- The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
- Bachelor’s Degree in Life Science, Chemistry, Pharmacy (Advanced Degree preferred).
- A minimum of three (3) years of in CMC regulatory activities, or a minimum of five (5) years with relevant experience in the pharmaceutical industry.
- Excellent scientific and clinical expertise.
- Regulatory Affairs certified
- Bilingual highly preferred
- Experienced with the submission of NDSs, ANDSs, DINs,, MDLs (Preferred: combination products).
- Knowledge of GUI-001 (Health Canada GMP), 21 CFR 210, 211 and 820 (FDA GMP)
- Knowledge of submission structured in CTD and e-CTD dossier preparation.
- Well-organized, strong ability to manage projects and priorities.
- Attention to details – Thoroughness
- Ability to read and interpret regulations governing the manufacture and marketing of prescription drugs and devices.
- Ability to assess how changes in currently marketed products will affect existing regulatory filings.
- Excellent verbal and written communication skills and interpersonal skills.
- Skilled in planning, organizing, coordinating projects, multi-tasking, and working independently.
- Proficient in Microsoft Office.
- Excellent attention to detail.
What we offer
Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
- Publication: PUB224840
- Location: Mississauga
- Market: LifeSciencesAndHealthCare
- Hours per week: 37
- Branche: Medicaldevices
- Education level: AcademicBachelor
- Area of expertise: Regulatory
- Closing date: September 19, 2019
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