Regulatory Affairs Specialist
3 days ago
Bausch Health Canada is a leading pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.
Key Responsibilities:- Plan, manage, and coordinate the preparation, compilation, and approval of high-quality regulatory submissions for presentation to Health Canada in eCTD format.
- Prepare and review responses to Health Canada letters in a timely manner, ensuring prompt regulatory approvals of dossiers under review.
- Evaluate change controls, determine necessary requirements, and prepare and compile L3 submissions to maintain product conformity and lifecycle.
- Critically assess data and documents to identify gaps compared to regulatory requirements.
- Maintain and ensure regulatory product compliance, interacting with internal and external stakeholders like Health Canada.
- Stay current with regulatory guidelines (Health Canada, ICH, etc.)
- Support the Sr. Manager RA-CMC as necessary.
- University Degree, B.Sc. or higher, in Health Sciences, with a DESS in Drug Development and/or RAC certification an asset.
- Relevant Quality Assurance/Compliance experience and CMC experience in Canadian Pharmaceutical Regulatory Affairs, with expertise in managing drug products and lifecycle.
- Strong working knowledge of Canadian regulatory guidelines, drug development, manufacturing, and commercialization of pharmaceutical products.
- Excellent organizational and communication skills, with the ability to prioritize projects, coordinate multiple projects simultaneously, and work with tight deadlines.
- Bilingual (English and French).
- Computer Literacy – Microsoft Package, including Word, Excel, and Outlook, Adobe Acrobat, Veeva, Docubridge, Trackwise.
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Regulatory Affairs Specialist
2 weeks ago
Laval, Quebec, Canada Bausch Health Companies Full timeBausch Health Companies is a leading international pharmaceutical company dedicated to delivering quality health and wellness products to Canadians. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring the company's products meet regulatory requirements and are approved for market. Your expertise will be essential in preparing...
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Regulatory Affairs Specialist
2 weeks ago
Laval, Quebec, Canada Bausch Health Companies Full timeBausch Health Companies is a leading international pharmaceutical company dedicated to delivering quality health and wellness products to Canadians. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring the company's products meet regulatory requirements and are approved for market. Your expertise will be essential in preparing...
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Regulatory Affairs Specialist
2 weeks ago
Laval, Quebec, Canada Bausch & Lomb Full timeRegulatory Affairs Specialist **Job Summary** Bausch Health Canada is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for planning, managing, and coordinating the preparation, compilation, filing, and approval of high-quality regulatory submissions for...
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Regulatory Affairs Specialist
2 weeks ago
Laval, Quebec, Canada Bausch & Lomb Full timeRegulatory Affairs Specialist **Job Summary** Bausch Health Canada is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will be responsible for planning, managing, and coordinating the preparation, compilation, filing, and approval of high-quality regulatory submissions for...
-
Regulatory Affairs Specialist
2 weeks ago
Laval, Quebec, Canada Bausch & Lomb Full timeRegulatory Affairs SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Key Responsibilities:Plan, manage, and coordinate the preparation,...
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Regulatory Affairs Specialist
2 weeks ago
Laval, Quebec, Canada Bausch & Lomb Full timeRegulatory Affairs SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Key Responsibilities:Plan, manage, and coordinate the preparation,...
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Regulatory Affairs Specialist
5 days ago
Laval, Quebec, Canada Bausch & Lomb Full timeRegulatory Affairs SpecialistBausch Health Canada is a leading pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Key Responsibilities:Plan, manage, and coordinate the preparation, compilation, and...
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Regulatory Affairs Specialist
5 days ago
Laval, Quebec, Canada Bausch & Lomb Full timeRegulatory Affairs SpecialistBausch Health Canada is a leading pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Key Responsibilities:Plan, manage, and coordinate the preparation, compilation, and...
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Regulatory Affairs Specialist
2 weeks ago
Laval, Quebec, Canada Bausch & Lomb Full timeJob Title: Senior Regulatory Affairs SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Key Responsibilities:Prepare and compile regulatory...
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Regulatory Affairs Specialist
2 weeks ago
Laval, Quebec, Canada Bausch & Lomb Full timeJob Title: Senior Regulatory Affairs SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Key Responsibilities:Prepare and compile regulatory...
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Regulatory Affairs Specialist
1 week ago
Laval, Quebec, Canada Bausch & Lomb Full timeJob Title: Senior Regulatory Affairs SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Key Responsibilities:Prepare and compile regulatory...
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Regulatory Affairs Specialist
1 week ago
Laval, Quebec, Canada Bausch & Lomb Full timeJob Title: Senior Regulatory Affairs SpecialistBausch Health Canada is a leading international pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Key Responsibilities:Prepare and compile regulatory...
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Senior Regulatory Affairs Specialist
3 weeks ago
Laval, Quebec, Canada Bausch Health Full timeCareer Opportunities: Senior Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Bausch Health. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our pharmaceutical products.Key...
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Senior Regulatory Affairs Specialist
3 weeks ago
Laval, Quebec, Canada Bausch Health Full timeCareer Opportunities: Senior Regulatory Affairs SpecialistJob Summary: We are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at Bausch Health. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our pharmaceutical products.Key...
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Regulatory Affairs Specialist
1 week ago
Laval, Quebec, Canada Bausch Health Companies Full timeBausch Health Companies is a leading international pharmaceutical company dedicated to delivering high-quality health and wellness products to Canadians. Our team is responsible for manufacturing and marketing a wide range of pharmaceutical and health products that are distributed across the country. We are seeking a highly skilled Senior Regulatory Affairs...
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Regulatory Affairs Specialist
1 week ago
Laval, Quebec, Canada Bausch Health Companies Full timeBausch Health Companies is a leading international pharmaceutical company dedicated to delivering high-quality health and wellness products to Canadians. Our team is responsible for manufacturing and marketing a wide range of pharmaceutical and health products that are distributed across the country. We are seeking a highly skilled Senior Regulatory Affairs...
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Regulatory Affairs Specialist
7 days ago
Laval, Quebec, Canada Bausch Health Full timeCareer Opportunities: Senior Regulatory Affairs SpecialistBausch Health Canada is a leading pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Key Responsibilities:Prepare and compile regulatory...
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Regulatory Affairs Specialist
7 days ago
Laval, Quebec, Canada Bausch Health Full timeCareer Opportunities: Senior Regulatory Affairs SpecialistBausch Health Canada is a leading pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. Our team manufactures and markets a wide range of pharmaceutical and health products distributed across the country.Key Responsibilities:Prepare and compile regulatory...
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Regulatory Affairs Specialist
3 weeks ago
Laval, Quebec, Canada Bausch & Lomb Full timeJob SummaryBausch Health Canada is a leading pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our products with Canadian regulatory requirements.Key ResponsibilitiesPrepare and compile regulatory submissions to...
-
Regulatory Affairs Specialist
3 weeks ago
Laval, Quebec, Canada Bausch & Lomb Full timeJob SummaryBausch Health Canada is a leading pharmaceutical company dedicated to bringing quality health and wellness products to Canadians. As a Senior Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our products with Canadian regulatory requirements.Key ResponsibilitiesPrepare and compile regulatory submissions to...