Regulatory Affairs Expert: Lead Product Safety and Compliance
1 week ago
We are seeking a seasoned Senior Manager to lead our Regulatory Affairs team in ensuring compliance with product safety and regulatory requirements. As a key member of our Scientific team, you will be responsible for managing the submission and approval process for new products.
Key Responsibilities- Provide strategic guidance on regulatory affairs to R&D and business partners to support development of product programs.
- Prepare, review, and file submissions for ANDA/ANDS, NDA/NDS, IND, and DMF in the eCTD format, as well as Rx to OTC Switches.
- Determine and communicate submission and compliance requirements to stakeholders within the company.
- Manage approval of assigned new products and claims, manage changes to existing products, and maintain compliance with applicable government regulations.
- University degree in a scientific field (Life Sciences, Chemistry, Pharmacology/Toxicology or Pharmacy).
- 10+ years of experience in regulatory affairs, including direct experience in submission and shepherding of product registrations for drug products, focusing on Canadian, USA, UK, and European Union regulatory schemes.
- 5+ years of leadership or management experience.
- Demonstrated proven record of negotiating product approvals with regulators and innovating regulatory strategies.
This role offers an estimated annual salary range of $120,000 - $180,000, commensurate with experience. Additionally, you will receive comprehensive benefits, including generous vacation and personal days, 6 months of paid parental leave, work-from-anywhere options, and more.
About UsAt Deciem, we value innovation and employee growth. We offer unlimited access to LinkedIn Learning, professional development grants, and an Employee Assistance Program. Join our team and take your career to the next level.
-
Regulatory Compliance Expert
1 week ago
Toronto, Ontario, Canada mccainfood Full timeAbout the RoleWe are seeking a highly skilled Regulatory Compliance Expert to join our team at McCain Foods. This is a full-time position located in Toronto HQ or Florenceville-Bristol, New Brunswick, Canada.Job Summary:The Regulatory Compliance Expert will be responsible for ensuring regulatory compliance of our products in the Canadian market. This...
-
Toronto, Ontario, Canada Deciem Full timeWe are seeking a highly skilled Senior Manager, Regulatory Affairs, Product Safety to join our Scientific team at DECIEM. This role will be based out of our head-office in Liberty Village.Key Responsibilities:Provide regulatory guidance and strategy to R&D and business partners to support development of product programs.Prepare, review, and file ANDA/ANDS,...
-
Toronto, Ontario, Canada Deciem Full timeWe are seeking a highly skilled Senior Manager, Regulatory Affairs, Product Safety to join our Scientific team on a full-time, permanent basis. This position will be based out of our head-office in Liberty Village.Key Responsibilities:Provide regulatory guidance and strategy to R&D and business partners to support development of product programs.Prepare,...
-
Regulatory Affairs Manager
1 month ago
Toronto, Ontario, Canada beBee Professionals Full timeProduct Compliance Specialist:BeBee Professionals is seeking a Regulatory Affairs Specialist to ensure the company's products comply with regulatory requirements. The ideal candidate will have a strong understanding of regulatory requirements and be able to interpret and apply them to the company's products.Responsibilities: Prepare and submit regulatory...
-
Toronto, Ontario, Canada Deciem Full timeKey ResponsibilitiesWe are seeking a seasoned Regulatory Affairs Senior Manager to lead our Product Safety team. The ideal candidate will have a strong background in product registrations, labelling, and marketing, with experience in managing global regulatory strategies.Develop and implement global regulatory strategies for new product registrations,...
-
Compliance Specialist
1 week ago
Toronto, Ontario, Canada Scotiabank Full timeAt Scotiabank, we are committed to excellence in compliance and regulatory affairs. We are seeking a highly skilled Compliance Specialist to join our team in Toronto, Canada.About the RoleWe are looking for an experienced Compliance Specialist with a strong background in regulatory affairs to lead compliance testing engagements for our Canadian operations....
-
Compliance Expert for Regulatory Affairs
1 week ago
Toronto, Ontario, Canada The Toronto-Dominion Bank (Canada) Full timeAbout the JobAs a Senior Compliance Business Oversight Officer at The Toronto-Dominion Bank (Canada), you will be a key member of our Canadian Banking Compliance team. Your primary responsibility will be to provide guidance, oversight, and expertise to our businesses on regulatory requirements and controls.This role is ideal for an individual with excellent...
-
Compliance and Regulatory Expert
1 month ago
Toronto, Ontario, Canada beBee Professionals Full timeRegulatory Affairs Specialist Job Description:BeBee Professionals is looking for a skilled Regulatory Affairs Specialist to join our team in Toronto. The successful candidate will be responsible for ensuring our products comply with applicable regulations and standards.Key Responsibilities: Prepare and submit regulatory documents, such as registration...
-
Regulatory Affairs Specialist
1 month ago
Toronto, Ontario, Canada beBee Professionals Full timeJob Title: Regulatory Affairs SpecialistJob Summary:BeBee Professionals is seeking a highly skilled Regulatory Affairs Specialist to ensure the company's products comply with applicable regulations and standards. The ideal candidate will have a strong understanding of regulatory requirements and be able to interpret and apply them to the company's...
-
Regulatory Affairs Specialist
1 month ago
Toronto, Ontario, Canada mccainfood Full timeJob Summary:The Regulatory Affairs Specialist will be responsible for ensuring product compliance with Canadian regulations and guidelines. This role will involve interpreting legislation requirements, developing and maintaining regional procedures, and supporting business partners on new product development and product reformulations.Key...
-
Regulatory Affairs Director
1 month ago
Toronto, Ontario, Canada Innomar Strategies Full timeAt Innomar Strategies, we are seeking a highly skilled and experienced Regulatory Affairs professional to join our team. As a key member of our team, you will be responsible for providing expert guidance and support to our clients in the pharmaceutical and biologic industries.Key Responsibilities:Develop and implement regulatory strategies for pharmaceutical...
-
Toronto, Ontario, Canada Coca Cola Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Expert to join our team in Toronto, Ontario, Canada. As a key member of our Scientific and Regulatory Affairs (SRA) function, you will play a critical role in ensuring compliance with food regulations and enabling business growth through innovative solutions.About the RoleThis exciting opportunity...
-
Regulatory Affairs Director
3 weeks ago
Toronto, Ontario, Canada Deciem Full timeWe are seeking a seasoned Regulatory Affairs professional to lead our Product Safety and Compliance efforts. Key Responsibilities:Provide strategic guidance on regulatory matters to R&D and business stakeholders.Prepare, review, and submit regulatory filings for new product registrations, including ANDA/ANDS, NDA/NDS, IND, and DMF.Determine and communicate...
-
Toronto, Ontario, Canada Coca Cola Full timeJob DescriptionAs a Scientific and Regulatory Affairs Compliance Manager at The Coca-Cola Company, you will play a crucial role in ensuring the company's beverages meet regulatory requirements and industry standards. Your expertise in scientific and regulatory affairs will enable business growth through innovation and compliance.Key Responsibilities-...
-
Regulatory Affairs Manager
1 month ago
Old Toronto, Ontario, Canada Lock Search Group Full timeRegulatory Affairs ManagerGreater Toronto AreaAbout the roleOur client is a global specialty-driven pharmaceutical company committed to giving hope to patients with difficult-to-treat diseases and limited options.SummaryAs a Manager, Regulatory Affairs, you will be responsible for leading the development and implementation of the Canadian regulatory...
-
Toronto, Ontario, Canada Coca Cola Full timeJob SummaryWe are seeking a highly skilled Scientific and Regulatory Affairs Compliance and Innovation Manager to join our team at The Coca-Cola Company. This role will be responsible for ensuring compliance with regulatory requirements and driving innovation in our scientific and regulatory affairs functions.Key ResponsibilitiesDevelop and implement...
-
Regulatory Affairs Specialist
4 weeks ago
Toronto, Ontario, Canada Deciem Full timeWe are seeking a highly organized and detail-oriented Regulatory Affairs Specialist to lead packaging creation for new product development, commercial expansion, and brand enhancements. This role will also be responsible for maintaining regulatory compliance for all DECIEM packaging in all markets.Key Responsibilities:Lead packaging creation for new product...
-
Compliance Expert
1 week ago
Toronto, Ontario, Canada Momentum Financial Services Group_new Full timeAbout Momentum Financial Services GroupMomentum Financial Services Group is a leading financial services organization committed to delivering exceptional services to its clients. With a strong focus on regulatory compliance, we are seeking a highly skilled Compliance Expert to join our team.Job SummaryWe are looking for a seasoned Compliance Expert to...
-
Regulatory Affairs Professional
1 month ago
Toronto, Ontario, Canada beBee Professionals Full timeRegulatory Affairs Specialist Role:BeBee Professionals is looking for a Regulatory Affairs Specialist to ensure the company's products meet regulatory requirements. The successful candidate will have a strong understanding of regulatory requirements and be able to interpret and apply them to the company's products.Key Responsibilities: Prepare and submit...
-
Regulatory Affairs Specialist
1 week ago
Toronto, Ontario, Canada Deciem Full timeRole OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in a full-time and permanent capacity. This role will be based out of our Head Office in Liberty Village and offer candidates the flexibility to work a hybrid model, with 2 days in-office and 3 days work-from-home.About the RoleThis position involves leading packaging...