Regulatory Affairs Specialist

4 weeks ago


London Ontario KZ, Middlesex, Canada Alimentiv Inc Full time

Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. May be required to coach peers and/or provide input for staff performance reviews.

Unit Management
  • Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites.
  • Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices, communicating changes to project leaders in a timely manner.
Client Services
  • As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.
  • Represent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client.
Regulatory Strategy Development
  • Identify changes in clinical research regulatory requirements and industry best practices and recommend, implement, and maintain corporate regulatory strategies, working with other experts (safety, quality assurance) when appropriate, to meet or exceed compliance requirements of evolving regulatory initiatives.
  • Participate in specialized conferences/meetings to increase knowledge as needed.
Project Support
  • Regularly respond to registration requests and work with project teams to identify regulatory requirements.
  • Assist in the preparation of regulatory submissions and support summaries.
  • Ensure project/clinical site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements.
Qualifications
  • Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
  • The successful candidate will possess strong knowledge of EMA regulations.
Working Conditions
  • Home-based
#J-18808-Ljbffr

  • London, Ontario, K5Z, Middlesex, Canada Volkswagen Group of America Full time

    Job Description - Indigenous Relations Specialist (St. Thomas) (ST.000077) Indigenous Relations Specialist (St. Thomas) - ST.000077 Primary Location We love our cars, but it’s the people behind them who make them what they are. To market, sell, and service great cars, we need great people. That’s why at Volkswagen Group Canada, we are passionate about...

  • Mortgage Specialist

    3 weeks ago


    London, Ontario, K5Z, Middlesex, Canada Scotiabank Full time

    Press Tab to Move to Skip to Content Link Select how often (in days) to receive an alert: Title: Mortgage Specialist - London, Windsor & Sarnia Requisition ID: 189501Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. Join us as we build a high-performing, purposed driven, winning sales team, anchored...

  • Financial Advisor

    4 weeks ago


    London, Ontario, K5Z, Middlesex, Canada MD Financial Management Full time

    Requisition ID: 200196 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. As a Financial Consultant you will contribute to the overall success of MD Wealth in Canada ensuring specific individual goals, plans, initiatives are executed / delivered in support of the team’s business strategies and objectives....

  • Financial Advisor

    1 month ago


    London, Ontario, K5Z, Middlesex, Canada MD Full time

    Requisition ID: 200196Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture.As a Financial Consultant you will contribute to the overall success of MD Wealth in Canada ensuring specific individual goals, plans, initiatives are executed / delivered in support of the team’s business strategies and objectives....

  • Mortgage Specialist

    4 weeks ago


    London, Ontario, K5Z, Middlesex, Canada Scotiabank Full time

    Requisition ID: 189501 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. Join us as we build a high-performing, purposed driven, winning sales team, anchored by an inclusive, client-focused culture. Job Purpose: We are currently seeking a passionate and results-driven Home Financing Advisor (HFA) to join...

  • Mortgage Specialist

    4 weeks ago


    London, Ontario, K5Z, Middlesex, Canada Scotiabank - Global Banking and Markets Full time

    Requisition ID: 189501Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture.Join us as we build a high-performing, purpose driven, winning sales team, anchored by an inclusive, client-focused culture.Job PurposeWe are currently seeking a passionate and results-driven Home Financing Advisor (HFA) to join our...

  • Mortgage Specialist

    3 weeks ago


    London, Ontario, K5Z, Middlesex, Canada Scotiabank Full time

    Requisition ID: 189501 Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture. Join us as we build a high-performing, purpose driven, winning sales team, anchored by an inclusive, client-focused culture.Job Purpose: We are currently seeking a passionate and results-driven Home Financing Advisor (HFA) to join our...


  • London, Ontario, K5Z, Middlesex, Canada The Toronto-Dominion Bank Full time

    Direct Investing Phone Specialist (London) Work Location: Canada Hours: 37.5 Line of Business: Personal & Commercial Banking Pay Details: We’re committed to providing fair and equitable compensation to all our colleagues. As a candidate, we encourage you to have an open dialogue with a member of our HR Team and ask compensation related questions, including...

  • Corporate Counsel

    4 weeks ago


    London, Ontario, K5Z, Middlesex, Canada Serv Recruitment Agency Full time

    Working HereAt CARFAX Canada, we're more than just obsessed with cars. We're obsessed with data and using it to help millions of Canadians buy, sell and maintain cars. Let's talk about the sweet perks you'll get when working here:In-house leadership training coursesCatered lunches with team matesState-of-the-art office at 100 Kellogg...


  • London, Ontario, K5Z, Middlesex, Canada Scotiabank Full time

    Requisition ID: #Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture.PurposeThe Franchise Specialist is part of a national team responsible for leveraging market area expertise for the profitable growth of the Bank’s franchising portfolio in their region and for developing new customer acquisitions.In this...


  • London, Ontario, K5Z, Middlesex, Canada Scotiabank Full time

    Requisition ID: 205463Join a purpose driven winning team, committed to results, in an inclusive and high-performing culture.PurposeThe Franchise Specialist is part of a national team responsible for leveraging market area expertise for the profitable growth of the Bank’s franchising portfolio in their region and for developing new customer acquisitions.In...


  • London, Ontario, K5Z, Middlesex, Canada TD Full time

    Lieu de travail: Canada Horaire: 37.5 Secteur d’activité: Services bancaires personnels et commerciaux Détails de la rémunération: Nous avons à cœur d’offrir une rémunération juste et équitable à tous nos collègues. En votre qualité de candidat ou de candidate, nous vous encourageons à avoir une conversation franche avec votre recruteur et...


  • London, Ontario, K5Z, Middlesex, Canada RhynoCare Full time

    The Opportunity Join us as a passionate leader to oversee and manage the nursing program at one of our vibrant Long Term Care communities. As an expert clinician, you are able to strategically guide and support a team of talented healthcare professionals who have a strong desire for delivering exceptional care. As a specialist in your field you have the...


  • London, Ontario, K5Z, Middlesex, Canada Voices Full time

    The Accounts Receivable position involves managing and recording incoming payments from clients, reconciling accounts, generating invoices, and communicating with customers to resolve payment discrepancies. It requires attention to detail, proficiency in financial software, excellent communication skills, and the ability to ensure timely collection of...

  • Senior Governance

    4 weeks ago


    London, Ontario, K5Z, Middlesex, Canada TD Bank Full time

    Nous utilisons des témoins pour fournir et améliorer nos services de sorte à vous offrir une expérience plus personnalisée, et les services de suivi sont désactivés. Pour en savoir plus sur les témoins utilisés et pour consulter vos préférences, veuillez vérifier les paramètres de votre navigateur ou sélectionner Accepter pour consentir à...


  • London, Ontario, K5Z, Middlesex, Canada Safran Full time

    Description du poste This position will be reporting directly to the Site Manager and will be responsible for developing, implementing and leading all supply chain activities of the site (inventories, procurement, repair scheduling, logistics), with the aim of reducing costs and lead times, while increasing productivity. Will be responsible for the...

  • HR Business Partner

    4 weeks ago


    London, Ontario, K5Z, Middlesex, Canada Canduct Industries Limited Full time

    Human Resources Business PartnerCanduct Industries has a career opportunity for an energetic, people and results-oriented Human Resources professional. The key mandate will be to champion the people agenda aligned with business strategies, objectives, retention, and growth. This role is ideal for a solutions-oriented individual who will bring strong HR...

  • Laboratory Analyst

    2 months ago


    London, Ontario, Middlesex, Canada Trudell Medical International Full time

    As a member of our Medical & Scientific Affairs team, you will perform and assist in the experiments undertaken to assess the dose and delivery characteristics of medical aerosol delivery devices.Responsibilities Include:Testing and EvaluationDevelop performance and failure analysis data for developmental, quality assurance, regulatory and marketing purposes...


  • Strathroy, Ontario, N7C, Middlesex, Canada Catalent Full time

    Facility and Maintenance Supervisor Position Summary Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is...


  • London, Canada Alimentiv Inc Full time

    Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools,...


  • London, Canada Alimentiv Inc Full time

    Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools,...


  • Kingston, Ontario, A7K, Lennox and Addington, Canada Adecco Full time

    Adecco is currently hiring a full-time Regulatory Affairs Specialist with a specialization in customer service to work for our client, who is dedicated to innovation and excellence, in Stouffville, ON. This role is essential in ensuring compliance with regulatory requirements and supporting the development and approval of our clients' products. In this...


  • Golden Horseshoe, Ontario, CA Adecco Full time

    Adecco is currently hiring a full-time Regulatory Affairs Specialist with a specialization in customer service to work for our client, who is dedicated to innovation and excellence, in Stouffville, ON. This role is essential in ensuring compliance with regulatory requirements and supporting the development and approval of our clients' products. In this...


  • Etobicoke, Ontario, Toronto, Canada Give and Go Prepared Foods Full time

    Give & Go Prepared Foods Corp. is a proud member of the Mondelēz family and has been a leading and growing North American manufacturer of baked goods for over 30 years. Its an exciting time to be part of the Give & Go team as we are growing rapidly and want you to become a part of our growth and extraordinarily bright future!Job Overview:As the Regulatory...


  • Ontario, Canada Brunel Full time

    Regulatory Affairs Team Lead (renewable contract)Remote – Ontario or Quebec IntroductionWe are hiring a Regulatory Affairs Team Lead for our client to work remotely in Ontario or Quebec. The Regulatory Affairs Team Lead will provide leadership to Managed Services team (Regulatory Affairs Project Leader, Documentation Specialist) and be accountable for...


  • Golden Horseshoe, Ontario, CA Nestlé SA Full time

    Position SnapshotBusiness area: Nestlé Canada Inc.Location: North York, ON located at 25 Sheppard Ave W, North York, ON M2N 6S8; HybridA little bit about usWhile Nestlé is known for KitKat, Gerber, Nescafe, and Häagen-Dazs, our recipe for success comes down to one thing: our people. We strive to lead a people-focused culture that empowers employees to...


  • Ontario, Canada Brunel Full time

    Regulatory Affairs Team Lead (renewable contract) Remote – Ontario or Quebec Introduction We are hiring a Regulatory Affairs Team Lead for our client to work remotely in Ontario or Quebec. The Regulatory Affairs Team Lead will provide leadership to Managed Services team (Regulatory Affairs Project Leader, Documentation Specialist) and be accountable...


  • Ontario, Canada Brunel Full time

    Regulatory Affairs Team Lead (renewable contract) Remote – Ontario or Quebec Introduction We are hiring a Regulatory Affairs Team Lead for our client to work remotely in Ontario or Quebec. The Regulatory Affairs Team Lead will provide leadership to Managed Services team (Regulatory Affairs Project Leader, Documentation Specialist) and be accountable for...


  • Ontario, Canada Brunel Full time

    Regulatory Affairs Team Lead (renewable contract)Remote – Ontario or Quebec IntroductionWe are hiring a Regulatory Affairs Team Lead for our client to work remotely in Ontario or Quebec. The Regulatory Affairs Team Lead will provide leadership to Managed Services team (Regulatory Affairs Project Leader, Documentation Specialist) and be accountable for...


  • Ontario, Canada Brunel Full time

    Regulatory Affairs Team Lead (renewable contract)Remote – Ontario or Quebec IntroductionWe are hiring a Regulatory Affairs Team Lead for our client to work remotely in Ontario or Quebec. The Regulatory Affairs Team Lead will provide leadership to Managed Services team (Regulatory Affairs Project Leader, Documentation Specialist) and be accountable for...


  • London, Canada Alimentiv Full time

    **Unit Management**: - Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites. - Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current...

  • Quality Assurance

    1 month ago


    Guelph, Ontario, Wellington region, Canada LUMINOR Environmental Inc. Full time

    Job Title: Quality Assurance & Regulatory Affairs SpecialistReports To: Manager, Quality AssuranceLocation: Guelph, ONJob Type: Full Time, Salaried Join LUMINOR Environmental Inc. and ensure excellence in water treatment solutions for home and industry!About Us:At LUMINOR Environmental Inc., we believe in creating and providing innovative Ultraviolet (UV)...


  • Ontario, Canada, Canada Brunel Full time

    Regulatory Affairs Team Lead (renewable contract)Remote – Ontario or Quebec IntroductionWe are hiring a Regulatory Affairs Team Lead for our client to work remotely in Ontario or Quebec. The Regulatory Affairs Team Lead will provide leadership to Managed Services team (Regulatory Affairs Project Leader, Documentation Specialist) and be accountable for...


  • Old Toronto, Ontario, CA Canadian Investment Regulatory Organization Full time

    Senior Corporate Communications and Public Affairs Specialist Job Category: Professional / Technical Requisition Number: SENIO002217 Apply now Posted : July 15, 2024 Full-Time Locations Showing 1 location Toronto Head Office 40 Temperance Street Suite 2600 Toronto, ON M5H0B4, CAN Toronto Head Office 40 Temperance Street Suite 2600 Toronto,...

  • Quality Assurance

    4 weeks ago


    Guelph, Ontario, L1E, Durham region, Canada LUMINOR Environmental Inc. Full time

    Job Title: Quality Assurance & Regulatory Affairs Specialist Reports To: Manager, Quality Assurance Location: Guelph, ON Job Type: Full Time, Salaried Join LUMINOR Environmental Inc. and ensure excellence in water treatment solutions for home and industry! About Us: At LUMINOR Environmental Inc., we believe in creating and providing innovative Ultraviolet...

  • Regulatory Specialist

    3 months ago


    London, Canada 3M Full time

    **Job Description**: Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can...


  • Markham, Ontario, York region, Canada Kelly Science, Engineering, Technology & Telecom Full time

    We are currently recruiting for a contract position for our pharmaceutical client for an ONSITE role. Location: Thornhill (Markham)- Hybrid/OnsiteDuration: 6 months contract with potential for extension Regulatory Affairs AssociateRole: Responsible for regulatory activities in support of assigned Aesthetic and/or Consumer business unit products including...


  • Mississauga, Ontario, C4W, Peel region, Canada F. Hoffmann-La Roche Gruppe Full time

    Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...


  • Mississauga, Ontario, C4W, Peel region, Canada F. Hoffmann-La Roche Gruppe Full time

    Roche fosters diversity, equity, and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...