Regulatory Affairs Consultant

Regulatory Affairs Consultant
at ClinChoice (View all jobs)
Toronto, Ontario Canada
About ClinChoice
ClinChoice is a clinical stage CRO dedicated to offering high-quality one-stop service to biopharmaceutical, medical device, and consumer products clients. Some of these services include clinical operations, project management, biostatistics, data management, Regulatory Affairs, medical affairs, and pharmacovigilance. ClinChoice has established major delivery centers across US, Canada, China, Europe, India, Japan and the Philippines. It has over 3,000 employees globally, with a strong and talented team, and a growing clinical operations presence in seven countries across Asia, North America and Europe.
Responsibilities:

• Coordinate regulatory projects from initiation to completion, ensuring adherence to timelines and milestones.
• Assist in the preparation and submission of regulatory documents, including applications, reports, and filings.
• Monitor regulatory developments and communicate updates to relevant stakeholders.
• Maintain regulatory documentation and ensure accuracy and completeness.
• Collaborate with cross-functional teams to gather information and support regulatory activities.
• Participate in regulatory meetings and provide support as needed.
• Assist in the preparation of responses to regulatory agencies and support regulatory inspections, as required.
• Contribute to process improvement initiatives to enhance regulatory compliance efficiency and effectiveness.
• Participate in Global Planning Meetings to get update of upcoming demand/ planned requests. Share the anticipated demand with stakeholder (fulfillers, Point of Contact)
• Receive requests in Triage and allocate them according to the guidelines. Facilitate discussions on due dates and manage communication with requesters to ensure adherence to the agreed-upon plan.
• Allocate the requests to the fulfillers team, provide assistance wherever needed.
• Prepare/review and coordinate routing of documents requiring Company’s representative’s signatures
• Coordinate notarization, apostille and/or legalization of regulatory documents as necessary
• Ensure accuracy checks and consistency of documents intended for submissions
• With minimal oversight, prepare and review different letters used for submission
• Provide assistance with data/document/information retrieval from searching through internal Company tools.

Qualifications:

• Bachelor's degree in a related field (e.g., Regulatory Affairs, life sciences, chemistry, biology).
• Minimum of 1 year of experience in Regulatory Affairs or a related role.
• Strong understanding of regulatory requirements and processes.
• Excellent organizational and time management skills.
• Attention to detail and ability to manage multiple priorities simultaneously.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively in a fast-paced environment.
• Proficiency in Microsoft Office Suite and regulatory software/tools (e.g., regulatory databases, document management systems) preferred.

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.
We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.