Managed Services Specialist
Canada, Ontario
Fulltime: 40 hrs a week
Experience: 2-4 Years
Pharmaceuticals
Introduction
Managed Services Specialist, Regulatory Affairs (renewable contract)
Remote - Ontario or Quebec
What are you going to do
Responsibilities
- File regulatory submissions (from the company's portfolios) to Health Canada to maintain compliance for marketed products with a focus on product monographs and drug labels.
- Update required the company's internal systems and databases with regulatory affairs information, as per their SOP's such as Vault RIM.
- Communicate and work with the company's local (eg, Canada brand team) and global stakeholders, according to their SOPs.
- Prepare ASMF (Active Substance Master File) regulatory submissions to Health Canada.
- Interact directly with Health Canada, and to address questions on filed submissions to ensure approval.
- Create detailed Yearly Biologic Product Reports (YBPR) by gathering data from the CPID, following regulatory guidelines and coordinating communication with key stakeholders.
- Oversee and coordinate the submission of Public Release of Clinical Information (PRCI), ensuring clear communication with internal teams and Health Canada.
Essential skills and knowledge
- Requirements
- Bachelor degree in pharmacy or any health-related field.
- Minimum of 1-3 years previous experience in the preparation of regulatory submissions specific to innovative drugs.
- English (written and spoken), French is an asset.
- Good understanding of the current Health Canada regulations and guidelines (CMC, clinical, and labeling).
- Good team work and ability to work independently.
- Computer knowledge of Microsoft Office Suite; Adobe Acrobat.
- Organised, attention to detail and deadline driven.
What we offer
What We Offer
Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you: from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding. We'll get you going while you get on with the job.
About Us
Brunel has a reputation for working with some of the best in the business. That's what we continually strive for. Over 45 years, we've created a global network of interesting clients and talented individuals working together through a vast array of services.
Anything else ?
Shape your future
Are you ready for the next step in your career? Join Brunel’s powerful global network, where passionate, results-driven specialists come together with industry-leading clients. By connecting specialists to pioneering projects, we drive change in many industries, enabling growth and delivering great outcomes. Brunel helps you reach your full potential and empowers you to make an impact within a purpose-driven global company.
Explore your career opportunities!
Explore your career opportunities!
Our Culture and Values
At Brunel, we are proud of our unique corporate culture, which is shaped and nurtured by the collective efforts of our employees. Our work environment is characterised by an authentic, communicative and inclusive approach to teamwork that fosters an atmosphere of collaboration and creativity. Our values are at the center of everything we do – for our clients, our colleagues and ourselves.
Learn more about our global network of specialists!
Learn more about our global network of specialists!
Our ESG Commitment
Since 1975, our mission has always been to connect specialists to exciting career opportunities, to support the development of these careers, and to offer fair and equal employment. This has enabled us to create a truly sustainable and durable business model. Having a passion for people and caring deeply for the environment is not only part of Brunel’s DNA but is also reflected in our culture and values. As a global company, we take our social responsibility very seriously.
Join us on our mission!
Join us on our mission!
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