Hybrid 2-3 days/week in-office work/downtown Toronto 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 and expand our portfolio. As we grow our team to support our growing client base, we are looking for an experienced Senior Specialist, RA with profound knowledge in Health Canada regulations to handle assigned RA tasks and provide guidance to secure clients' trust and confidence.

You will work alongside the executive management, support the execution of high-quality work to fulfil our client promises and directly support the expansion of the company.

Main Responsibilities:

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 Operations. Maintain strict confidentiality regarding all client projects, internal team operations, and sensitive information at all times. Contribute to Health Canada pre submission meetings. Handle and manage PM updates with strict timelines as requested by clients. Support with NDSs and ANDSs for wide range of product categories including the preparation of supporting documentation and response handling. Handle eCTD submissions on behalf of partner clients. Support with labeling and packaging updates and review activities to ensure compliance with regulations and liaise with the clients as needed. Handle RMP drafting in support with the drug application, as applicable Support ongoing CMC filings Participate in project onboarding and mapping client timelines for successful product launch. Liaise with global partners and affiliates to obtain relevant dossier information, when 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 professional with minimum 5 years of experience in the Canadian environment In-depth understanding of Canadian regulatory requirements for pharmaceuticals, and natural health products. Technical knowledge to support eCTD submissions. Excellent written and verbal communication abilities in English and French. Strong 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 9:00am to 5:00pm

Work Location: Hybrid in Toronto, ON M5C 1X6, or remote in Montreal (QC)