Regulatory Affairs Associate

5 months ago

Toronto, Canada Translational Research in Oncology Full time

Translational Research in Oncology (TRIO) is a global academic clinical research organization dedicated to advancing translational cancer research in the clinical trial setting. Our passionate team is committed to providing cancer treatments of the future to the world of today.

TRIO is looking for a
**Regulatory Affairs**
**Associate to** join our
**Regulatory Affairs**
***team reporting to the
**Global Head of Regulatory Affairs**
**.** This position will be home-based, office-based or hybrid-based depending on which city the successful applicant lives in.

**Responsibilities**:

- Effectively communicate the status and action plans concerning regulatory submissions and advise the project team about appropriate regulatory strategies as needed.
- Provides review and analysis of applicable regulatory guidelines and project regulatory assessments as needed, in consultation with the Global Head, Regulatory Affairs
- Review and make recommendations on relevant dossier documentation (i.e., labels, to comply with ICH GCP and country specific requirements.
- Actively review new regulatory updates globally and communicate pertinent information to responsible teams.

**Qualifications**:

- Diploma or Degree in Regulatory Affairs or scientific/medical discipline.
- A minimum of two years of clinical research experience, notably in a regulatory-related function (less experience would be considered if you hold a specialization in Regulatory Affairs obtained through initial education program or on-going training/experience).
- Good knowledge of ICH GCP, and relevant clinical research/regulatory requirements in either the US, Canada, or EU.
- Fluent in oral and written English; multilingualism is beneficial (but not required).

**What TRIO Can Offer You**:

- Competitive Salary
- 3 weeks of vacation plus paid Christmas Closure
- 2 weeks paid personal/sick time
- Health, Dental, Vision & Life Insurance premiums paid by TRIO
- Flexible working hours
- Monthly internet allowance
- Up to 5% RRSP Matching Program

Pay Range: $55,000 to $75,000 - Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.
**Innovation - Teamwork - Passion **-** **Integrity**

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