8 Health Canada Jobs

- Provide remote QMS support for global sites, handling OOS, OOT, deviations, incidents and change controls. - Review documentation for compliance & drive continuous improvement. - Ensure timely investigation, analysis & change control initiation. Required Candidate profile - 9+ years of QC/QA experience in regulated pharma co. - Reviewing OOS, OOT, APQR & lab incident investigations, change controls & managing deviations - Strong knowledge of USFDA, EU & Health Canada

Required 4 - 5yrs regulatory experience candidate with specialization in M Pharm (Pharmaceutics) Job Description Filing requirements with respect to Module 2 & 3 ability to independently and correctly review technical documents related to Quality Module Well versed with Regulatory guidance and Processes (i.e., Ability to understand and interpret technical expectations during review cycle) Clear Knowledge of basic aspects of a formulation (primarily pharmaceutical development) for effective review of R&D documents. Should be aware of post approval variation requirements. Should have basic QA knowledge to enable correct review of plant related documents

Job Title Norm Compliance Officer Job Description Norm Compliance Officer The purpose of this position is to handle end-to-end Norm Compliance activities for Diagnostic X-ray systems as part of the Research and Development team, with all relevant mandatory international and national regulations. Your role: Defining all applicable global product safety certification, product safety, EMC and environmental (if applicable) standards like IEC, EN, and ISO standards required to comply with all applicable international regulations. Define and review product requirements related to guidance, codes and standards to assure norm compliance and decomposition of standard requirements to the individual sy...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem...

About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com. Job Summary Responsible for auditing Apotex Enterprise sites, Apotex and Apotex Pharmachem ...

PopVax, an Indian biotechnology company based in Hyderabad, with a primarily remote US subsidiary nominally located in New York, is seeking a senior regulatory executive. The company is funded through research agreements with the Gates Foundation and Vitalik Buterin's biosecurity company, Balvi. Over the past year, PopVax has been developing a novel second-generation mRNA platform for low-cost broadly-protective vaccines using computationally-driven antigen design. The primary focus is on an open-source booster vaccine candidate designed to provide protection against the entire sarbecovirus species and potentially the betacoronavirus genus, including current and future strains of SARS-CoV-2,...

Job Summary: We are looking for a highly skilled and experienced Clinical Research Scientist with a strong background in Bioequivalence and Bioavailability (BE/BA) studies and clinical operations . The ideal candidate will have over 10 years of experience in the pharmaceutical industry, with a minimum of 7 years in BE/BA studies, and a deep understanding of regulatory requirements for highly regulated markets including USFDA, EMA (EU), and Health Canada . This role also involves overseeing clinical trials as a Sponsors Representative , managing end-to-end clinical processes, ensuring regulatory compliance, and coordinating with various stakeholders for successful study execution and document...

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents f...