Job Description

Location: Hybrid with 3 days/week in-office work/downtown Toronto, or Remote in Montreal.

Type: Full-time, permanent (No Health Benefits)

Your Role:

Zenith PV Solutions Inc. is a leading provider of a full range pharmacovigilance and regulatory services to the pharmaceutical industry in Canada. Our philosophy to provide the best quality of service and focus on client satisfaction has allowed us to grow rapidly through client referrals. As we grow our team to support our growing client base, we are looking for an experienced

Associate Director; RA, PV & Compliance

with profound knowledge in the Canadian Regulatory Affairs, Pharmacovigilance and Quality Compliance to support the daily operations, perform assigned daily activities, provide guidance to the RA/PV team and secure clients' trust and confidence.

You will work alongside the executive management, support the execution of high-quality work to fulfil our client promise and directly support the growth of the company. Your impact will be felt across the organization, shaping the future of Zenith.

Main Responsibilities:

Oversee internal QMS documentation completeness for compliance and audit-readiness purposes. Ensure timely execution of PV project milestones, proactively addressing potential delays or deviations from the agreed scope of work. Implement effective troubleshooting strategies to resolve challenges that could impact internal or external deadlines, ensuring continuity of operations. Support routine PV activities as needed Conduct audits on behalf of clients, including vendor audits and self-inspections, ensuring compliance with applicable regulations and client-specific requirements. Support the Director of PV Operations in preparing for and managing internal self-inspections and regulatory inspections on behalf of clients. Oversee the workload distribution among team members, ensuring equitable task allocation and efficient resource utilization and provide periodic performance reports and constructive feedback to promote growth and accountability. Foster a collaborative and supportive team environment to achieve organizational objectives and ensure high-quality outputs. Maintain strict confidentiality regarding all projects, internal team operations, and sensitive information at all times. Support with the regulatory strategy for new products and lifecycle management on behalf of clients and plan their execution for successful submission to Health Canada. Support the RA due-diligence process requests on behalf of clients for new drugs to be registered in Canada along side the Director of PV Operations. Contribute to Health Canada pre submission meetings. Support CTAs, RMPs, sNDS, NC, SAP, including the preparation of supporting documentation and response handling. Handle eCTD submissions along with assigned partner clients. Oversee labeling and packaging activities to ensure compliance with regulations and liaise with the clients as needed.

Required Qualifications and Experience:

Holds MSc. or equivalent from a recognized Canadian university in pharmaceutical and health sciences, pharmacology, pharmacy or other relevant programs. A qualified RA and PV professional with 10-12 years of experience in the Canadian environment In-depth understanding of Canadian regulatory requirements for pharmaceuticals, natural health products, and medical devices Technical knowledge to support eCTD submissions Excellent written and verbal communication abilities in English and French Project Management Skills Dynamic with ability to prioritize and manage projects independently to ensure efficient workflow and goal achievement Adapt quickly to changes in responsibility, based on client needs, with ability to handle multiple clients and projects effectively

Zenith's Commitment:

We're committed to fostering a culture of excellence and integrity, where your contributions directly impact patient safety and client satisfaction.

If you're driven to make a difference and value a collaborative environment, we invite you to apply in confidence.

Zenith PV Solutions Inc. is an equal opportunity employer, valuing diversity and inclusivity.

Only candidates who meet our screening criteria will be contacted.

Job Types: Full-time, Permanent

Schedule:

Monday to Friday
Work Location: Hybrid remote in Toronto, ON M5C 1X6

Application deadline: 2025-07-25