Assistant Manager, Regulatory Affairs

Job Details

●        Location: Suite 1600, 2300 Yonge Street, Toronto, Ontario (On-site; may be deployed to client site based on project requirements)

●        Employment Type: Full-Time, Permanent

●        Hours: 40 hours per week

●        Wage: $52.54 per hour

●        Start Date: ASAP

●        Vacancies: 1

●        Language: English

Position

●        Job Title: Assistant Manager, Regulatory Affairs

●        Department: Regulatory Affairs / Regulatory Publishing

●        Reporting to: Warren Strauber / Director, MPR Publishing and Submission

Job Duties

●        Provide guidance and support to internal business units on regulatory policies and procedures; ensure internal compliance with regulatory requirements.

●        Prepare and coordinate regulatory submissions and filings with regulatory bodies.

●        Produce regulatory publishing deliverables (e.g., INDs, NDAs, NDSs, MAAs, annual reports, routine submissions, Clinical Study Reports) in accordance with US, EU, Canada and other global requirements, using electronic publishing tools and an EDMS system.

●        Perform independent publishing QC on published output, complete appropriate checklists and/or provide assessments for the activities around the quality of report-level publishing and submission readiness of source documents for submission-level publishing.

●        Act as liaison, coordinating regulatory publishing activities with other multidisciplinary teams.

●        Regulatory Technology Innovation and AI-Based Process Optimization.

●        Lead regulatory product projects and provide subject-matter expertise on regulatory publishing and authoring activities.

●        Conduct assessments and propose improvements to regulatory operations methods, systems, and procedures in areas such as operations, human resources, records management, and communications.

●        Support the preparation, submission, tracking, and archival of electronic and paper regulatory submissions.

●        Maintain awareness of evolving regulatory and industry standards across US, EU, Canada, and Australia–New Zealand markets.

Job Requirements

●        Bachelor's degree (or equivalent) in pharmacy, life sciences, regulatory affairs, or a related field

●        Minimum 6 years of relevant experience in regulatory affairs/regulatory publishing within the pharmaceutical or life sciences industry

●        Demonstrated experience with product registration procedures (IND, NDA, NDS, CTA, BLA, IMPD, MAA) for regulated markets such as the US, EU, Canada, and Australia–New Zealand

●        English language proficiency

Benefits

●        Medical Insurance, Dental, Vision,  2 weeks of Vacation Time, 12 days of Casual Leave (which can be used as vacation or sick days), plus applicable holidays.

How to Apply

●        Submit your resume and cover letter to hr@freyrsolutions.com.