Regulatory Affairs Specialist

7 months ago


Mississauga, Canada Cliantha Research Ltd. Full time

**Job Description / Roles and Responsibilities for Job Title**:
**1)** Maintain an excellent knowledge of clinical trials/clinical research and a thorough understanding of industry regulatory requirements

**2)** Stay current on regulatory updates and issue regular communications bulletins within the organization

**4)** Communication with the regulatory agencies (e.g., Health Canada, EMEA, FDA) and/or via the sponsor in response to regulatory issues raised in regulatory documents such as clarifaxes or deficiency letters

**5)** Conduct and support all other Regulatory submissions, including but not limited to, SAEs, End of Study Notifications, Amendments, responses to clarifaxes and/or other submissions queries/questions/observations, etc.

**8)** Completion of Bioequivalence Summary Tables and Comprehensive Summary - Bioequivalence Report for Submission to regulatory authorities

**9)** Creation and maintenance of regulatory resources for the company with respect to the following regulatory bodies: Health Canada, FDA, EMEA, MHRA; others as needed

**10)** Register appropriate clinical trials with ClinicalTrials.gov as per FDAAA 801 requirements

**11)** Provide regulatory advice and input as required

**12)** Work in a safe manner that does not endanger yourself or co-workers

**13)** Delegate tasks as appropriate to members within the regulatory team in order to meet timelines efficiently

**14)** Preparation of other submissions not identified above, if/as requested (i.e. Ethics, etc.)

**15)** Execute other duties as required by RA Management
- **Any Additional responsibility given by Head of the Department / Management**_

**Qualifications**:

- Bachelor of Science (B.Sc.) degree in life sciences
- Post-graduate Regulatory Affairs certification an asset
- Minimum 1-3 years regulatory affairs experience within the pharmaceutical/CRO industry
- Current with regulatory requirements pertaining to clinical research (Health Canada, FDA), ICH, GCP, GDP, GMP, GLP, Code of Federal Regulations (21CFR)
- Experience associated with the conduct of activities pertaining to registrations and submissions with Health Canada, FDA (IRBs an asset)
- Possess a highly developed regulatory mindset as it pertains to BE and phase I-IV clinical trials
- Strong analytical and problem solving skills
- Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
- Excellent interpersonal skills
- Strong written and verbal communication skills

**Salary**: $45,000.00-$80,000.00 per year

**Benefits**:

- On-site parking

Flexible Language Requirement:

- French not required

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Mississauga, ON L4W 1A4: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's Degree (preferred)

Work Location: In person



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