Associate, Regulatory Affairs
3 days ago
The Associate, Regulatory Affairs will prepare regulatory submissions for complex injectable products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. The Regulatory Affairs Associate will provide sound regulatory input during product development. KEY RESPONSIBILITIES Coordinates the assembly, including requesting and/or generating, of documents to support submissions including complex generics and biosimilars (NDS, ANDS, DINA, etc.) per established business processes and systems Fulfills lifecycle management activities as needed to support the base business objectives and improve existing portfolio by compiling and submitting post-approval changes (SANDS, SNDS, Post DINA) Liaises with external partners/CMOs to request documents and ensures regulatory compliance is met for the purpose of filing successful submissions Builds and maintains a healthy working relationship with business partners. Liaises with partners to collect documents and information for submission preparation or in response to technical queries/deficiency letters. Evaluates and ensures that submissions are accurate and meet format and content requirements as per Health Canada regulations Communicates effectively with internal departments (Quality, Supply Chain, Marketing, etc.) to assist in the continuation of product supply Reviews, evaluates, prepares, and files deficiency responses for changes filed with Health Canada in a timely manner within given deadlines Contributes to an efficient and effective regulatory affairs team and uses knowledge and expertise towards a culture of continuous improvement Maintains current awareness of Health Canada regulatory guidelines and shares knowledge with the department TECHNICAL SKILLS Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner Knowledge of GMP requirements and QA/QC procedures Strong understanding of Health Canada and ICH regulatory guidance documents and policies Proficient computer skills, including MS Office applications and Adobe Acrobat; Experience with eCTD publishing tools is an asset Demonstrated understanding of sterile product manufacturing is preferred QUALIFICATIONS Bachelor’s Degree in Science or Life Sciences and post-graduate certification in Regulatory Affairs program Must have a minimum of 3 years of experience in drug submissions for Canada, preferably with parenteral dosage forms SteriMax is an equal opportunity employer that is committed to fair and accessible employment practices for all existing staff and potential candidates. Please advise Human Resources if you require an accommodation to participate in the recruitment process #J-18808-Ljbffr
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Associate, Regulatory Affairs
3 days ago
Oakville, Canada SteriMax Inc. Full timeThe Associate, Regulatory Affairs will prepare regulatory submissions for complex injectable products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. The Regulatory Affairs Associate will provide sound regulatory input during product development.KEY...
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Associate, Regulatory Affairs
6 days ago
Oakville, Ontario, Canada SteriMax Inc. Full timePOSITION DESCRIPTION:The Associate, Regulatory Affairs will prepare regulatory submissions for complex injectable products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements. The Regulatory Affairs Associate will provide sound regulatory input during product development.KEY...
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Associate, Regulatory Affairs
2 weeks ago
Oakville, Canada AmerisourceBergen Full time- What you will be doing PRIMARY DUTIES AND RESPONSIBILITIES:_ - Co-ordinate and compile regulatory submissions, responses to agency questions and other correspondence in accordance with requirements for assigned projects - Implement an agreed upon action plan to achieve timely approval of regulatory submissions which ensure compliance with applicable...
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Oakville, Canada SteriMax Inc. Full timeA pharmaceutical company in Oakville, Ontario, is seeking an Associate in Regulatory Affairs to prepare regulatory submissions for complex injectable products. The ideal candidate will have at least 3 years of experience with drug submissions in Canada, particularly for parenteral dosage forms. Responsibilities include coordinating submission documentation,...
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Oakville, Canada SteriMax Inc. Full timeA pharmaceutical company in Oakville, Ontario, is seeking an Associate in Regulatory Affairs to prepare regulatory submissions for complex injectable products. The ideal candidate will have at least 3 years of experience with drug submissions in Canada, particularly for parenteral dosage forms. Responsibilities include coordinating submission documentation,...
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Regulatory Affairs Manager
2 weeks ago
Oakville, Canada AceAge Full timeAceAge is a healthcare technology company, creating intuitive products to improve health outcomes and empower patients to live healthier and better lives. In close collaboration with healthcare personnel and our users, we have developed Karie - a personal health companion that organizes, schedules and dispenses medication with one-button technology. With...
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Regulatory Affairs Specialist
2 weeks ago
Oakville, Canada Natus Medical Incorporated Full time**Regulatory Affairs Specialist** ***Oakville, ON** **As a TEAMMATE**: The **Regulatory Affairs Specialist** specializes in understanding international regulatory requirements to support the proper design and development of medical devices. You could expect to work with product development teams to ensure that our products meet regulatory compliance...
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Oakville, Canada Natus Medical Incorporated Full timeRegulatory Affairs Specialist: 12-month Contract Job Description Posted Monday, January 19, 2026 at 8:00 AM FOR MORE THAN 80 YEARS , Natus has been working in collaboration with clinicians to deliver industry‑leading neuro solutions that help providers more easily make sense of the body’s signals. Engineered with input from those who have lived the care...
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Oakville, Canada Natus Medical Incorporated Full timeRegulatory Affairs Specialist: 12-month Contract Job Description Posted Monday, January 19, 2026 at 8:00 AM FOR MORE THAN 80 YEARS, Natus has been working in collaboration with clinicians to deliver industry‑leading neuro solutions that help providers more easily make sense of the body’s signals. Engineered with input from those who have lived the care...
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Oakville, Ontario, Canada Natus Medical Incorporated Full timeFOR MORE THAN80 YEARS, Natus has been working in collaboration with clinicians to deliver industry-leading neuro solutions that help providers more easily make sense of the body's signals.Engineered with input from those who have lived the care experience, our technology simplifies complex processes and improves accuracy and efficiency. There is a role for...
