Location

Benefits

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Full job description

Position Overview

Our rapidly expanding team is seeking a Senior Regulatory Affairs Associate to support the regulatory affairs and clinical operations teams located in Guelph, ON. The Senior Regulatory Affairs Associate will provide leadership and support for various clinical and regulatory projects. The main responsibilities of the successful candidate will include the oversight and preparation of various regulatory submissions to support clinical trials and market access while ensuring compliance with applicable global policies, procedures, and regulatory guidelines.

Primary Responsibilities

· Prepares of regulatory submissions and related documentation to primarily Health Canada, including Natural Health Product (NHP) Clinical Trial Applications (CTAs), Master Files, and Product License Applications (PLA), according to current Agency requirements.

· Interacts with internal and external groups to provide regulatory affairs consultative support for projects.

· Initiates and manages regulatory affairs projects to ensure content complies with emerging or new requirements.

· Identifies gaps in submission dossier to meet local requirements.

· Leads and provides guidance in the development and implementation of regulatory strategies.

· Liaises with functional areas to coordinate and compile information required for regulatory documentation.

· Ability to communicate and resolve any complex issues and activities related to regulatory submissions.

· Interprets and makes decisions relating to regulatory guidelines and policies.

· Advises management on changes to regulations, standards and legal stipulations, and ensures SOPs are updated to reflect such changes.

· Liaises with Health Canada and other regulatory agencies, as needed.

· Keeps abreast of domestic and global regulatory trends, laws. and movements.

· Maintains positive and cooperative communications and collaboration with all internal and external stakeholders.

· Other duties as required and as training and experience allows.

· Promotes GXP compliance across the organization.

· Maintains an attitude and philosophy consistent with the company's standards.

Core Competencies:

· Extensive knowledge and experience in the Natural Health Products Regulations, associated regulatory principles, processes, and industry standards.

· Excellent organizational time management and communication skills.

· Excellent interpersonal and public relation skills with ability to work well in a team.

· Solid problem-solving skills with an ability to identify solutions to problems under critical deadline constraints.

· Strong technical writing skills, and ability to review and critique regulatory documents.

· Ability to work independently with efficiency and accuracy and high attention to detail.

· Computer literacy with MS Office and Adobe Acrobat.

Qualifications

· Bachelor’s degree in a scientific discipline or equivalent qualification.

· Regulatory affairs certificate or post-graduate diploma in Regulatory Affairs is preferred.

· Minimum 5 years specific experience in regulatory sciences, with dossier writing/submission experience.

We thank all candidates for their applications, however, only those candidates selected for an interview will be contacted.

Job Type: Full-time

Job Type: Full-time

Benefits:

• Dental care
• Extended health care
• On-site parking
• Paid time off

Schedule:

• Monday to Friday

Work Location: In person