Regulatory Affairs/ Product Registrations Manager (Mississauga)

Regulatory Affairs/ Product Registrations Manager (Mississauga)

04 Aug
|
Cerapie Pharma
|
Mississauga

04 Aug

Cerapie Pharma

Mississauga

Company Description Cerapie Pharma is a well-established Canadian pharmaceutical manufacturer known for its commitment to quality, safety, and regulatory compliance. The organization focuses on developing and producing pharmaceutical products that meet rigorous national and international standards. Team members collaborate across functions to support innovation, continuous improvement, and reliable product supply.

Joining Cerapie

Pharma offers opportunities to contribute to patient well-being while working in a structured, professionally driven environment.

Role Description The Regulatory Affairs/Product Registrations Manager is a full-time, on-site role based in Mississauga, ON. This position is responsible for planning, preparing, and submitting regulatory applications and product registrations for Canadian and international markets, ensuring compliance with applicable regulations and guidelines. Day-to-day tasks include coordinating with internal departments to gather technical documentation, maintaining regulatory dossiers, tracking submission timelines, and responding to health authority queries.

The role also involves monitoring regulatory changes, updating internal procedures, and supporting audits and inspections.



The manager will collaborate with quality, manufacturing, and commercial teams to ensure product labels, promotional materials, and technical information meet regulatory and company standards.

Qualifications

Strong knowledge of Canadian and international pharmaceutical regulations, guidelines, and registration pathways.

Experience preparing, reviewing, and managing regulatory submissions, product licenses, variations, and renewals.

Ability to interpret technical and scientific data, with attention to detail in documentation and record-keeping.

Skilled in cross-functional collaboration, stakeholder communication, and project coordination in a regulated setting.

Proficiency with regulatory information systems, document management tools, and standard office software.

Bachelor’s degree or higher in Pharmacy, Life Sciences, Chemistry, or a related field; Regulatory Affairs certification is an asset.

Previous experience in a pharmaceutical manufacturing setting, preferably in regulatory affairs or quality-related roles.

Strong organizational, analytical, and problem-solving skills, with the ability to manage multiple projects and deadlines.

📌 Regulatory Affairs/ Product Registrations Manager (Mississauga)
🏢 Cerapie Pharma
📍 Mississauga

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