Regulatory Affairs Specialist Jobs
By NutriAg Ltd. At Etobicoke, Ontario, Canada
Self-motivated with organizational and time management skills
We offer a competitive salary, bonus structure and a comprehensive benefits package.
Excellent communication skills; both verbal and written. Fluency in Spanish or French will be an asset.
1-2 years of experience in registration would be an asset.
·Oversee all projects related to fertilizer product labels to ensure compliance requirements
University Degree in Science, Agriculture or Regulatory field
Sr. Associate, Regulatory Affairs
By Viatris At Etobicoke, Ontario, Canada
Demonstrated time management skills and the ability to prioritize and handle multiple projects is required.
Strong knowledge of Health Canada regulations and guidelines requirements.
Proficiency with Microsoft Office and Document Management Systems.
B.Sc. in one of the life sciences or chemistry with a minimum of 3-5 years hands-on experience in regulatory submission preparation.
Experience with documentation, organizing small projects, working in a deadline environment.
Proven ability to learn, correlate diverse data and extrapolate from set examples; documented organizational abilities.
Director – Regulatory & Technical Affairs
By Canadian Poultry and Egg Processors Council At Ottawa, Ontario, Canada
Facilitate discussions on interpretation and enforcement issues with CFIA headquarters, and potentially CFIA Regional Directors on issues affecting members.
Work with national producer groups on supply chain issues affecting food safety and animal health & welfare.
Participate as required, in industry, government and stakeholder meetings on behalf of CPEPC and represent its members.
Director – Regulatory & Technical Affairs,
Major areas of focus are:Food Safety and Animal Health & Welfare.Specific focuses include:
Regulatory Affairs Analyst Jobs
By The Scotts Miracle-Gro Company At Mississauga, Ontario, Canada
Solid knowledge of time/project management principles.
Skill Factors (education, experience, communication, technical, etc.)
Strong oral and written communication skills as well as presentation abilities.
Keeps current on regulatory requirements through self study/attendance at conferences/training seminars
Greater than three years Regulatory experience or related field (related disciplines may include environmental science, product development, toxicology, plant science, etc.)
Solid knowledge of provincial and/or federal government regulations.
Regulatory Affairs Associate - Iii----Hybrid
By US Tech Solutions At Mississauga, Ontario, Canada
Knowledge, Experience & Skills Required
Acts as a knowledgeable resource on limited topics to other Regulatory Affairs personnel within the department.
5+ years of relevant regulatory experience in the prescription pharmaceutical industry - experience in both clinical and CMC considered an asset.
Post-graduate certification in Regulatory Affairs is considered an asset.
Experience in Virology or Oncology considered an asset
Understanding and knowledge of the fundamentals of Canadian regulatory legislation and guidance.
Senior Regulatory Affairs Associate
By Boston Scientific At Mississauga, Ontario, Canada
Adhere to requirements of the Quality Management System.
Working knowledge of relevant EU regulatory requirements for medical devices including Quality Systems standards
A minimum of a bachelor's degree or equivalent work experience
Previous experience with EU MDR notified body reviews for Class III devices
Experience working directly with notified bodies is desired
Coordinates, compiles, and submits CE Mark submissions under the EU MDR
Policy Analyst, Regulatory Affairs, Parental Leave
By Bell At Ottawa, Ontario, Canada
Supporting the management of a large database of spectrum licences.
University degree or relevant working experience
Excellent written and oral communication skills.
Experience manipulating large datasets in Excel.
High level of proficiency with Microsoft Office (Word, Excel and PowerPoint).
Ability to quickly and clearly summarize complex documents.
Quality Assurance Regulatory Affairs Coordinator
By CPG Executive Search Inc. At Caledon, Ontario, Canada
· Organize and planning skills to effectively manage the flow of stock
· Ability to have the right mindset and attitude to freely share knowledge, knowhow, and skills
· Manages internal label documents ensuring only current and up-to-date labels are circulated.
· 4-7 years of regulatory experience in a regulatory, preferably in manufacturing environment
· Detail oriented, accurate and excellent record keeping skills
· Knowledge of Canadian and US Food Labelling Regulations is required
Regulatory Affairs Manager Jobs
By Canadian Hospital Specialties Limited At Oakville, Ontario, Canada
Develop and implement effective recall management procedures and processes.
Demonstrated leadership skills and experience in managing and mentoring a team.
Familiarity with quality management systems (e.g., MDSAP, QSR, GMP) and risk management (e.g., ISO 14971).
Quality Management System (QMS) Activities:
Ensure adherence to regulatory requirements throughout the product lifecycle.
Lead cross-functional teams in executing product recalls, ensuring compliance with regulatory requirements.
Pharmaceutical Regulatory Affairs Manager
By Collabera At Mississauga, Ontario, Canada
• Acts as a knowledgeable resource on limited topics to other Regulatory Affairs personnel within the department.
• Post-graduate certification in Regulatory Affairs is considered an asset.
• Experience in Virology or Oncology considered an asset
• Understanding and knowledge of the fundamentals of Canadian regulatory legislation and guidance.
• Excellent communication skills both in writing and verbally.
• Good judgment/ problem solving skills.
Regulatory Affairs Specialist Jobs
By Brunel At Mississauga, Ontario, Canada
Participate in cross-functional teams to support product development, regulatory strategy, and risk management activities.
In-depth knowledge of global regulatory requirements and guidelines pertaining to clinical trials and CMC aspects.
Familiarity with regulatory software and document management systems is a plus.
Review and approve manufacturing and analytical documentation, including batch records, specifications, and stability protocols/reports, to ensure compliance with regulatory requirements.
Experience in preparing and submitting regulatory filings (e.g., INDs, CTAs, IMPDs, MAAs).
Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to cross-functional teams.
Sr. Regulatory Affairs Specialist
By Integrated Resources, Inc ( IRI ) At Markham, Ontario, Canada
Proficiency with Microsoft Excel and general computer skills
hybrid work schedule with some on-site office and remote work
Ideal candidate background: previous regulatory affairs experience is preferred, especially experience with Medical devices
Job Title: Regulatory Affairs Specialist
Job Location: Markham, ON (Hybrid)
Job Duration: Until Aug 2024
Senior Regulatory Affairs Specialist
By Trudell Medical International (TMI) At London, Ontario, Canada
Report trends from product feedback to support continuous improvement, vigilance activities and management reviews
Knowledge of the requirements of an ISO 13485 quality program
Experience using database software to manage data and records is an asset.
Maintain current body of knowledge on regulations and standards that may impact regulatory approvals for products currently being marketed
Certificate in Regulatory Affairs or equivalent work experience
Minimum of 5 years of regulatory experience in a medical device environment
Regulatory Affairs Specialist 2 Jobs
By US Tech Solutions At Markham, Ontario, Canada
Ideal candidate background: previous regulatory affairs experience is preferred, especially experience with Medical device
Proficiency with Microsoft Excel and general computer skills
hybrid work schedule with some on-site office and remote work
Job Title: Regulatory Affairs Specialist 2
Location: Markham / Ontario / Canada L3R 0T5 - Hybird
Excellent communication and comprehension of the English language
Canada Senior Licensing Specialist, Regulatory Affairs
By GE Power At Markham, Ontario, Canada
Management experience in Regulatory Affairs or large engineering projects
2 or more years of experience with Canada nuclear requirements and guidance
Minimum of 1 year of experience involving complex projects, and providing regulatory guidance and feedback to support those projects
Experience and demonstrated effectiveness in working / communicating with nuclear regulators
Experience working with nuclear industry groups
Effective interpersonal and facilitation skills
Nuclear Licensing Specialist, Canadian Regulatory Affairs
By GE Power At Markham, Ontario, Canada
CNSC Licensing process and regulatory knowledge / technical knowledge of one or more areas, such as nuclear fuel, operating plants, etc.
Working knowledge of BWR/PWR systems, fuel, or operations
Experience and demonstrated effectiveness in working / communicating with CNSC personnel
Experience working with Canadian industry groups (i.e., Owners Groups) on nuclear licensing matters
Excellent technical writing skills with the ability to create technical reports suitable for a wide range of audiences
Effective interpersonal and facilitation skills
Sr. Analyst, Regulatory Affairs / Analyste Réglementaire Senior
By The Scotts Miracle-Gro Company At Mississauga, Ontario, Canada
Excellent skills in data management, information analysis and report writing.
Effective time and project management skills - Plans and organizes to meet deadlines
Skill Factors (education, experience, communication, technical, etc.)
Strong oral and written communication skills as well as presentation abilities.
Keeps current on regulatory requirements through self-study/attendance at conferences/training seminars.
Greater than five years Regulatory experience (or related fields)
Associate, Regulatory Affairs Jobs
By Natco Pharma (Canada) Inc. At Mississauga, Ontario, Canada
Excellent verbal and written communication, organizational, time-management and interpersonal skills.
Strong computer skills (Proficiency with MS Office and Adobe Acrobat Pro, and Document Management Systems).
Assess and update documentation for change controls in CMC and labelling according to quality change management systems.
Experience with eCTD submissions and knowledge of GMP and QA/QC procedures is preferred.
Request and review artwork that meets Health Canada’s plain language labelling requirements.
1-2 years of experience supporting drug product submissions to Health Canada
Remote Regulatory Affairs Specialist
By The Fountain Group At Ottawa, Ontario, Canada
This position will be working with multiple business units to develop, update, and improve regulatory affair processes.
Update and develop procedures for the regulatory affairs in supporting changes in the regulatory landscape, including EU MDR.
Identify opportunity for regulatory affair processes and drive changes to completion.
Regulatory Affairs Jobs
By Tag At Greater Toronto Area, Canada
•Experience in the delivery and management of complex quality assurance solutions
MUST HAVE EXPERIENCE AND INDICATED ON RESUME WITH MLR SUBMISSIONS, PAAB and VEEVA PROMOMATS SUBMISSIONS
•A Bachelor’s degree or equivalent experience is required
•Over 6 years’ experience in print and/or digital, or regulatory Quality Assurance environments
•Medical, pharmaceutical, or Life Sciences marketing experience preferred
•Excellent client facing and customer service skills
Regulatory Analyst Jobs
By Peak Power Inc At Greater Toronto Area, Canada
4 years of experience within the energy and regulatory space, preferably an understanding of IESO, NY-ISO, ISO-NE, PJM, and ERCOTT
Strong research, written communication skills, with a strategic mindset
Keep Learning. Sharpen your skills through continuous development paid for by Peak Power.
Cultivate an understanding of the various revenue stacks available within each ISO
Research and analyze large volumes of material and distill and summarize the most critical elements to provide relevant updates the business
Through a strategic lens, synthesize what the implications of these regulatory updates and changes mean for Peak Power
Regulatory Analyst Jobs
By Peak Power Inc At Ontario, Canada
The experience and education. You have proven experience delivering success in a fast-paced, multi-tasking role where you are comfortable working autonomously.
4 years of experience within the energy and regulatory space, preferably an understanding of IESO, NY-ISO, ISO-NE, PJM, and ERCOTT
Strong research, written communication skills, with a strategic mindset
Keep Learning. Sharpen your skills through continuous development paid for by Peak Power.
Cultivate an understanding of the various revenue stacks available within each ISO
Research and analyze large volumes of material and distill and summarize the most critical elements to provide relevant updates the business
Quality Assurance And Regulatory Affairs Analyst
By Intellijoint Surgical Inc. At Kitchener, Ontario, Canada
Experience working within a Quality Management System (QMS)
Strong organizational, time management, and prioritization skills.
Support system administration of Quality Management System software.
Skills and Experience to Enable Success:
A continuous learner that builds on their existing knowledge of medical device and biomedical technology regulations
Collaborate with cross-functional teams and interface with external parties to meet quality requirements within project timelines.
Director Of Regulatory Affairs
By Akkodis At Scarborough, Ontario, Canada
· 10 to 12 years working experience
Experience working directly with the FDA on regulatory filings/strategy is required
· Experience with electronic submissions/the electronic submission process
Knowledge of how regulatory agencies operate, structure and process
Staying updated on regulatory requirements:
Preparing and submitting regulatory submissions:
Vp, Regulatory Affairs Jobs
By Aviso Wealth At Toronto, Ontario, Canada
Extensive experience (minimum 12-15 years') in the wealth management industry
Strengthen and enhance compliance processes, supervisory controls, and risk management insights through technology
Delivery of key messages to senior management of Aviso, Credit Union executives and board of directors
Strong presentation skills and public speaking experience
Maintain a current and advanced knowledge of all regulations that pertain to the functions they administer and provide thought leadership
Strong and demonstrable experience in plain language writing and communication style
Aml Analyst (Global Affairs)
By Collabera At Toronto, Ontario, Canada
Critical thinker with strong writing skills
Manager gave is pushing for candidates to be given a written assignment before their interview
Past background in banking/financial in some capacity -- AML experience is nice to have but not required
Revising reviews based on manager feedback.
Mentality/personality to learn quickly in a fast-paced environment
To assist in Enhanced Due Diligence reviews for Capital Markets clients
Vp, Regulatory Affairs Jobs
By Aviso Wealth At Vancouver, British Columbia, Canada
Extensive experience (minimum 12-15 years') in the wealth management industry
Strengthen and enhance compliance processes, supervisory controls, and risk management insights through technology
Delivery of key messages to senior management of Aviso, Credit Union executives and board of directors
Strong presentation skills and public speaking experience
Maintain a current and advanced knowledge of all regulations that pertain to the functions they administer and provide thought leadership
Strong and demonstrable experience in plain language writing and communication style
Advisor, Regulatory Affairs Jobs
By Hydro One At Toronto, Ontario, Canada
A period of over 8 years and up to and including 10 years is considered necessary to gain this experience.
Assist with the formulation of process improvements to streamline regulatory approvals by ensuring efficient processing of regulatory submission.
Participate on OEB lead industry teams related with regulatory matters.
Perform other duties as required.
47282 - Toronto - Rotation - 12 Months
We are honoured to be recognized by Forbes in its list of Canada’s Best Employers for 2023.
Regulatory Affairs Advocacy Lead
By Mondelēz International At Greater Toronto Area, Canada
Excellent organizational, analytical, project management, and communication skills
Established professional network with hands on experience and skills interacting with food industry groups; preferred
Expertise in SARA core knowledges topics (flavors, food additives, GMO, organic, dietary requirements)
Strong attention to detail with a passion to advance regulatory compliance technical skills
6-10 years of Regulatory Affairs experience (senior level, strong compliance background)
Language skills for markets of geographic oversight for communication and correct interpretation of laws and regulations
Regulatory Affairs Specialist (Remote Us Or Canada)
By Kelly Science, Engineering, Technology & Telecom At Toronto, Ontario, Canada
Knowledge of the requirements of an ISO 13485 quality program
Experience using database software to manage data and records is an asset.
Maintain current body of knowledge on regulations and standards that may impact regulatory approvals for products currently being marketed
Certificate in Regulatory Affairs or equivalent work experience
1-2 years of regulatory experience in a medical device environment within Health Canada
Knowledge and understanding of regulations governing medical devices in Canada, US and Europe is an asset
Analyst, Indigenous & Regulatory Affairs
By Prospectors & Developers Association of Canada (PDAC) At Toronto, Ontario, Canada
 Knowledge of or direct Indigenous relations experience with First Nations, Inuit & Métis
 2-3 years of industry experience in the field of mineral and/or metal exploration; or
2-3 years experience working in policy analysis and advocacy or direct mineral exploration field
experience involving regulatory frameworks in Canada, or Indigenous relations/engagement;
 Ability to demonstrate knowledge of regulations/legislation related to land use planning, land
 Experience designing and implementing projects and programs in partnership with a diverse range of stakeholders;
Senior Regulatory Affairs Specialist
By STEMCELL Technologies At Vancouver, British Columbia, Canada
Be a valuable member of our risk management team, contributing from a regulatory perspective to risk assessment exercises and documents
Build partnerships, internally and externally, to provide routine updates and ensure compliance with regulatory requirements
A minimum of 3 years of experience in regulatory affairs within the medical device or life sciences industry
Proven experience in compiling and submitting pre-market regulatory submissions, such as 510(k), De novo, and IVDR Technical Documentation
Collaborate with cross-functional teams to provide regulatory inputs during the design and development phase of our devices
Compile pre-market submissions, including pre-submissions, 510(k), De novo, and IVDR Technical Documentation as necessary
Quality Assurance/Regulatory Affairs Specialist (14M Mat Leave Contract)
By DIVA At Kitchener, Ontario, Canada
Support maintenance of Diva’s ISO 13485 certification and Quality Management System as a whole.
Experience in the maintenance of Quality Management Systems, e.g., ISO 13485 and FDA QSR for medical devices;
Report on performance of the QMS to top management
Proficient in MS Office applications, quality management software & tools, and the ability to learn new software as required;
Prepare, upkeep and manage FDA, Health Canada, and other worldwide regulatory submissions as well as other regulatory related documents;
Ensure compliance with applicable regulatory standards/requirements;
Regulatory Affairs Specialist - Drug Development
By Jubilant Radiopharma At Kirkland, Quebec, Canada
Perform additional duties as assigned by Management
Bachelor’s degree with relevant experience in the pharmaceutical industry
Minimum of three (3) to five (5) years of relevant experience in the pharmaceutical industry.
Detail-oriented, reliable, autonomy and judgment capacity toward the application of regulatory requirements.
Excellent organization and planning skills
Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.
Director Of Regulatory Affairs
By Nuclear Fuel Services At Kanata, Ontario, Canada
Represents the regulatory group on product development teams and the core project team communicating regulatory requirements for product development.
Manages pharmacovigilance activities for the organization.
Provides oversight for any planned advertising/marketing of regulated products ensuring compliance with all regulatory requirements.
Experience with radiopharmaceutical, active pharmaceutical ingredients or medical devices in quality assurance, quality control or manufacturing is an asset.
Experience working directly with the FDA on regulatory filings/strategy is required. Similar experience with Health Canada is an asset.
Experience with electronic submissions/the electronic submission process
Regulatory Affairs Associate - Iii
By Netpace Inc At Montreal, Quebec, Canada
Acts as a knowledgeable resource on limited topics to other Regulatory Affairs personnel within the department.
Post-graduate certification in Regulatory Affairs is considered an asset.
Experience in Virology or Oncology considered an asset
Understanding and knowledge of the fundamentals of Canadian regulatory legislation and guidance.
Excellent planning and organizational skills and the ability to work simultaneously on several projects with tight timelines.
Excellent communication skills both in writing and verbally.
Regulatory Affairs Lead Jobs
By Nestlé At North York, Ontario, Canada
Successful line management with direct and indirect reports and exposure across several functions
Comprehensive total rewards benefits package including Health and Dental benefits that start on day one of employment
Access to Educational Assistance & Tuition Reimbursement
Additional discounts on a variety of products and services offered by our preferred vendors and partnerships
Advanced degree in Life Sciences or related area. A post-graduate diploma or certification in Regulatory Affairs is an asset.
Minimum 10 years' progressive experience in Regulatory Affairs within highly regulated food and health products.

Are you looking for a challenging and rewarding career in Regulatory Affairs? We are looking for a Regulatory Affairs Analyst to join our team and help us ensure compliance with all applicable regulations. You will be responsible for researching and analyzing regulatory requirements, preparing regulatory submissions, and providing guidance to internal stakeholders. If you have a passion for regulatory compliance and are looking for an opportunity to make a difference, this could be the perfect job for you!

A Regulatory Affairs Analyst is responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They are responsible for researching, interpreting, and communicating regulatory requirements to internal stakeholders, as well as providing guidance on regulatory compliance.

What is Regulatory Affairs Analyst Job Skills Required?

• Knowledge of applicable laws and regulations
• Excellent research and analytical skills
• Strong communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to work under pressure and meet deadlines
• Proficiency in Microsoft Office Suite

What is Regulatory Affairs Analyst Job Qualifications?

• Bachelor’s degree in a related field such as law, public policy, or business
• Relevant experience in regulatory affairs
• Professional certification in regulatory affairs (e.g. Regulatory Affairs Professional Society (RAPS) certification)

What is Regulatory Affairs Analyst Job Knowledge?

• Knowledge of applicable laws and regulations
• Understanding of the regulatory environment and its impact on business operations
• Knowledge of the product development process
• Knowledge of the regulatory submission process

What is Regulatory Affairs Analyst Job Experience?

• Previous experience in regulatory affairs
• Experience in a related field such as law, public policy, or business

What is Regulatory Affairs Analyst Job Responsibilities?

• Research and interpret applicable laws and regulations
• Develop and maintain regulatory compliance strategies
• Prepare and submit regulatory documents
• Monitor regulatory changes and updates
• Provide guidance and advice on regulatory compliance
• Liaise with internal and external stakeholders
• Track and report on regulatory compliance activities