Regulatory Affairs Associate

2 weeks ago

Toronto, Canada Mundipharma Full time

Company Description
- Elvium Life Sciences focuses on our existing products in the areas of CNS (ADHD), cancer supportive care, and ophthalmic conditions while continuing to advance on research and enhance treatment options for Canadians.

**Job Description**:

- We are looking for a Regulatory Affairs Associate to join our team at the Elvium Life Sciences Head Office in Markham, Ontario. This role supports the Canadian Regulatory Affairs team primarily with compiling and revising Regulatory documents and submissions that are accurate, complete, and in compliance with federal regulatory requirements.
- This is a permanent position that is pivotal in supporting the evolving needs of the organization. Hours of work are 37.5 weekly with the opportunity to work from home and in the office, when required. You will be joining an organization and a team that moves quickly, prioritizes our patients and customers, and is focused on doing the right thing.
- Responsibilities
- In association with the Regulatory Affairs Manager, develop Federal drug submissions, including S/NDSs, N/Cs, and DIN submissions. This includes obtaining, assessing and summarizing clinical and other technical information and developing rationales to support claims.
- Lead and support the management of electronic regulatory documentation and submissions and archive systems for effective utilization by the department. Including:

- Manages and structures electronic file transfers
- Maintains and develops submission templates
- Maintain electronic files on local servers and oversee archiving activities
- Prepare Product Monograph updates for labelling compliance with CCDS.
- Submit updated Prescribing Information to eCPS and send updates to Library Services to post on the company website.
- Prepare Marketing versions of TPD approved Product Monographs and distribute to relevant stakeholders, including Logistics and Marketing.
- Collaborate cross-functionally with Local and Global Scientific Affairs functions to provide information required for the compilation of global PSURs.

**Qualifications**:

- Completed Life Sciences College or University Degree or equivalent.
- Completed Post-Graduate Certificate in Regulatory Affairs.
- Experience of working in Regulatory Affairs in the Canadian pharmaceutical industry.
- Knowledge of Canadian drug laws, regulations, guidelines and policies, and the Health Authority organizational structure and processes for the review and approval of drug submissions.
- Knowledge and Skills
- Understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Acts and Regulations and knowledge of submission content and format.
- Understanding of pharmaceutical drug development process, including chemistry and drug manufacturing.
- Attention to detail and strong organizational skills for development of complex documentation.

Additional information
- Elvium Life Sciences is proudly an equal opportunities employer. We are committed to ensuring that our recruitment process supports our commitment to treating everyone fairly, drawing from the widest possible pool of talent that reflects the diversity of our global communities and our patients. We welcome and invite all qualified to bring their unique value forward and apply.

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