Regulatory Associate Consultant

3 months ago

Toronto, Canada ClinChoice Full time

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds.

ClinChoice is searching for a **Regulatory Associate Consultant** with **HYBRID** option in **Toronto, Ontario, CANADA **for a **3 months CONTRACT**, to join one of our major pharmaceutical clients.

**Responsibilities**
- Regulatory submission support under the direction of a IM Regulatory team member
- Coordination of the preparation and maintenance of regulatory submissions and filings
- Assess, prepare and compile regulatory submissions (e.g. safety labeling changes) and ad hoc reports to Health Canada and maintain the life cycle of currently marketed products.
- Assist in the preparation and submission of larger submissions including New Drug Submissions (NDSs), Supplemental New Drug Submissions (SNDSs).
- Assist in the preparation and review of responses to Health Canada queries (e.g. Clarifax, Notice of Non-Compliance [NON], and Notice of Deficiency [NOD]) in a timely manner.
- Engage with other functions and global regulatory teams to facilitate regulatory activities.
- Execute assigned regulatory activities to support compliance requirements and product labeling.
- Complete regulatory activities as assigned within required timelines to meet company and Health Canada requirements.

**Qualifications**:

- A minimum B.Sc. in Biological or related sciences.
- A minimum of 1 year of Regulatory Affairs pharmaceutical or related experience is required, preferably in Canada

**Required Regulatory Associate Core/Technical competency requirements**:

- Basic knowledge of the drug development process is required.
- 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 is required.
- Experience preparing and obtaining approval of therapeutic/labeling submissions
- Experience in eCTD submissions and knowledge of Health Canada eCTD regulations and requirements in specific
- Experience with managing the operational aspect of Canadian regulatory submissions (all types; NDS, SNDS, etc)
- Demonstrated project or submission management capabilities
- Demonstrated effective interpersonal, teamwork, and communication skills
- Ability to use Regulatory Information systems
- Ability to work in a matrix environment
- Good problem solving and analytical skills
- Therapeutic area and product knowledge is preferred
- Ability to exercise solid judgment and communicate effectively with varied levels of the organization required
- ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301._

LI-PR1 #LI-Hybrid #Contract

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