Specialist 2 - Regulatory Affairs
Full time
at US Tech Solutions
in
Canada
Posted on February 10, 2025
Job details
Job Name: Specialist 2 - Regulatory Affairs Job Location: TORONTO / ONTARIO / M3C 1L9 / CANADA Duration : 06 Months Responsibilities
- Regulatory submission support under the direction of a J&J 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 J&J functions and global regulatory teams to facilitate regulatory activities.
- Apply appropriate regulatory submission standards, requirements, processes, and policies to comply with applicable health agency requirements.
- 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.
- 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
- 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 capabilitie
- 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
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