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.
- Preparation of responses to clarification requests according to Health Canada’s deadlines
- 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 Guidance and Requirements.
- Ensures liaison with Health Canada for general regulatory matters and product-specific issues, including meetings and negotiations with the Agency.
- The job function listed is not exhaustive and shall include any responsibilities as assigned by the Supervisor from time to time.
- Bachelor’s Degree in Life Science discipline or equivalent;
- DESS in drug development;
- A minimum of three (3) years of Regulatory Affairs experience, preferably in a specialty pharmaceutical company;
- Excellent scientific and clinical expertise;
- Bilingual is required, both written and oral;
- Experienced with the submission of NDSs, ANDSs, DINs, MDLs (Preferred: combination products);
- Knowledge of Canadian regulations, as well as international regulations;
- Well-organized, strong ability to manage projects and priorities;
- Excellent attention to detail and thoroughness;
- Ability to read and interpret regulations governing the manufacturing and marketing of prescription drugs and devices;
- Excellent verbal and written communication skills and interpersonal skills;
- Skilled in planning, organizing, coordinating projects, multi-tasking, and working independently;
- Proficient in Microsoft Office.
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: PUB231779
- Location: Montreal
- Market: LifeSciencesAndHealthCare
- Hours per week: 37.5
- Branche: Pharmaceutical
- Education level: AcademicBachelor
- Area of expertise: Regulatory
- Closing date: November 3, 2019
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