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Regulatory Affairs Officer Jobs

Senior Regulatory Affairs Associate (Contract)
By Haleon At Mississauga, Ontario, Canada
Knowledge of submission requirements and timelines
Collaborate with global and local teams to manage critical timelines.
Post-secondary degree or relevant work experience
3-5 years of experience pharmaceutical/OTC industry experience in Regulatory Affairs
3-5 years of experience with submissions and negotiations with Health Canada
3-5 years of experience in OTC or Consumer Healthcare
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
Regulatory Affairs - Submission Publisher - Contract
By ClinChoice At Canada
· Current information on electronic document management and publishing to CLIENT’s Regulatory associates
· Educational Requirements: minimum bachelor’s degree in science
· Compile electronic- or paper-based-submissions necessary to meet regulatory requirements using available electronic publishing tools
· Provide support for data entry, maintenance, and retrieval from computer-based information systems
· Experience with a variety of computer software and systems. Familiarity with publishing tools preferred
· Demonstrate excellent communication skills (English language) – both oral and written
Translational Regulatory Affairs Director - Digital Health
By AstraZeneca At Mississauga, Ontario, Canada
Excellent organizational and project management skills.
At least 5 years of regulatory affairs experience or related knowledge/experience.
Extensive knowledge of digital health technologies and COAs in oncology and hematology drug development.
Previous demonstrated experience of regulatory drug development or equivalent, and experience with major Health Authority interactions (US or Ex-US)
A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.
Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
Regulatory Affairs Associate Director Uk/Ie
By Pharma Partners Recruitment Ltd At Essex, Ontario, Canada
A working knowledge and experience in CTAs, paediatric investigation plans and orphan designations.
Experience in regulatory affairs in pharmaceuticals and previous experience of managing teams.
Demonstrated experience of contact and relationship with MHRA and HPRA.
Responsibility of all UK/IE assigned Marketing Authorisation Applications for New Chemical Entities, Generics/Hybrids, devices, biosimilar and OTC products.
Formulate regulatory strategies for all products within the team for new submissions and post approval changes.
Lead or participate in preparations for health authority meetings and effectively chair discussions
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.
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.
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
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
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
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 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;
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.
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

Are you looking for an exciting opportunity to make a real difference in the healthcare industry? We are looking for a Regulatory Affairs Officer to join our team and help us ensure that our products meet all regulatory requirements. If you have a passion for regulatory compliance and a drive to make a positive impact, this could be the perfect job for you!

Overview: Regulatory Affairs Officers are responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They work closely with other departments such as research and development, marketing, and legal to ensure that products meet the necessary standards. They also provide advice and guidance on regulatory issues, and monitor changes in the regulatory environment. How to Become a Regulatory Affairs Officer: To become a Regulatory Affairs Officer, you must have a bachelor’s degree in a related field such as biology, chemistry, or engineering. You may also need to have experience in the field, such as working in a laboratory or in a regulatory agency. Regulatory Affairs Officer Skills: Regulatory Affairs Officers must have strong analytical and problem-solving skills, as well as excellent communication and interpersonal skills. They must also be able to work independently and as part of a team. Regulatory Affairs Officer Knowledge: Regulatory Affairs Officers must have a thorough understanding of the laws and regulations that apply to their company’s products and services. They must also be familiar with the relevant industry standards and guidelines. Regulatory Affairs Officer Responsibilities: Regulatory Affairs Officers are responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They must also provide advice and guidance on regulatory issues, and monitor changes in the regulatory environment. Regulatory Affairs Officer Experience: Regulatory Affairs Officers must have experience in the field, such as working in a laboratory or in a regulatory agency. Regulatory Affairs Officer Qualifications: Regulatory Affairs Officers must have a bachelor’s degree in a related field such as biology, chemistry, or engineering. Regulatory Affairs Officer Education: Regulatory Affairs Officers must have a thorough understanding of the laws and regulations that apply to their company’s products and services. They must also be familiar with the relevant industry standards and guidelines. Tools to Help Regulatory Affairs Officer Work Better: Regulatory Affairs Officers can use software such as Microsoft Office, Adobe Acrobat, and other document management systems to help them manage their work. They can also use online databases to stay up-to-date on the latest regulations. Good Tips to Help Regulatory Affairs Officer Do More Effectively: Regulatory Affairs Officers should stay organized and keep detailed records of their work. They should also be proactive in researching new regulations and staying up-to-date on changes in the regulatory environment.

Common Regulatory Affairs Officer Interview Questions:

• What experience do you have in regulatory affairs?
• How do you stay up-to-date on changes in the regulatory environment?
• What challenges have you faced in regulatory affairs?
• How do you ensure that a company’s products and services comply with all applicable laws and regulations?
• What strategies do you use to ensure compliance?