Regulatory Affairs Project Lead

3 weeks ago


Mississauga, Ontario, Canada Juno Pharmaceuticals Full time
Position Overview:

A Regulatory Project Manager at Juno Pharmaceuticals coordinates and manages assigned Regulatory Affairs projects to ensure successful growth and maintenance of the company's product portfolio in a fast-paced and rewarding environment.

Key Responsibilities include:

• Effectively manage assigned Regulatory Affairs projects independently and, when needed, collaborate with other staff or consultants to ensure a successful conclusion.

• Review technical dossiers/packages for accuracy, completeness, and compliance with regulatory requirements and prepare gap reports.

• Ensure that submissions meet format and content requirements and guarantee the accuracy and completeness of statements, data, and conclusions in reports and summaries for inclusion in Regulatory submissions.

• Build and maintain healthy working relationships with Regulatory Agencies, using these relationships to understand expectations beyond those presented in guidelines and policy statements.

• Organize and facilitate meetings and teleconferences to maintain progress of projects, track critical attributes of projects to ensure accountability and efficiency, and resolve any technical queries or deficiency letters relating to any submission in a timely manner within deadlines.

• Collaborate with senior decision-makers to provide technical direction and prepare Regulatory strategies for new products under assessment.

• Provide regulatory counsel to ensure that all activities comply with regulations and provide cross-functional input from an operational, scientific, and technical viewpoint.

• Monitor regulatory maintenance of approved drug products, maintain current awareness of regulatory guidelines (Health Canada, ICH, EMEA, FDA, etc.), review Change Controls, and determine filing requirements.

• Review and approve product labeling to meet regulatory requirements and review promotional material to ensure compliance with Health Canada regulations, PAAB guidelines, and/or ASC guidelines (as applicable).

• Perform other regulatory affairs functions and activities as assigned to achieve departmental or operational priorities and prioritize other responsibilities to meet additional work requirements.

Reports to: Regulatory Affairs Manager

How to Apply:

Please submit your resume to careers@junopharm for consideration.

  • Mississauga, Ontario, Canada Juno Pharmaceuticals Full time

    A challenging opportunity has arisen at Juno Pharmaceuticals for a Regulatory Affairs Project Lead to oversee the management and preparation of assigned projects. This role is critical in ensuring the successful growth and maintenance of our product portfolio in a fast-paced environment.Responsibilities:Independently manage Regulatory Affairs projects,...


  • Mississauga, Ontario, Canada Juno Pharmaceuticals Full time

    Regulatory Affairs Project ManagerA Regulatory Project Manager at Juno Pharmaceuticals plays a crucial role in ensuring the successful growth and maintenance of the company's product portfolio. This position involves effectively preparing and managing assigned Regulatory Affairs projects to meet regulatory requirements and ensure compliance.Key...


  • Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to lead our Oncology regulatory strategy, ensuring compliance with Health Canada regulations and guidelines. As a key member of our team, you will be responsible for developing and implementing regulatory strategies for our Oncology products, working closely with cross-functional teams...


  • Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Lead - Performance Optimization to join our team at Alectra Utilities Inc. This role will provide leadership and support to the Regulatory Affairs department, ensuring compliance with industry regulations impacting business operations.The successful candidate will have a strong background in...


  • Mississauga, Ontario, Canada F. Hoffmann-La Roche AG Full time

    Program ManagementAt F. Hoffmann-La Roche AG, we are seeking a skilled Regulatory Affairs Specialist to join our team. This role will be responsible for delivering global regulatory strategy and executing clinical projects in our portfolio, ensuring the development and maintenance of Roche product licenses to meet patient needs.In this position, you will...


  • Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with Health Canada regulations and guidelines.Prepare and submit regulatory documents, including NDSs, SNDSs, CTAs, and NCs, to achieve aggressive targets.Build and maintain relationships with Health Canada contacts to improve submission approval times and achieve...


  • Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Regulatory Affairs ManagerJob SummaryThe Regulatory Affairs Manager provides leadership and support to the Regulatory Affairs department, ensuring compliance with industry regulations and government codes. This role involves reviewing and assessing emerging regulatory issues, industry standards, and government initiatives, and providing advice and guidance...


  • Mississauga, Ontario, Canada BAXTER Full time

    Key Responsibilities:- Prepare and submit regulatory documents, including NDS, SNDS, Medical Device Applications, and CTAs, according to current Health Canada requirements.- Collaborate with stakeholders to provide accurate and timely responses to Health Canada, identifying priorities and key issues in complex situations and achieving resolution with minimal...


  • Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Regulatory Affairs and Compliance ManagerLocation: MississaugaRequisition #: 2024-209DescriptionThe OpportunityPosition Purpose: The Regulatory Affairs and Compliance Manager provides strategic leadership and support to the Regulatory Affairs department, ensuring compliance with industry regulations and business operations. This role reviews and assesses...


  • Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Key Responsibilities:Develop and implement regulatory strategies to ensure timely and successful product approvals in the Oncology therapy area.Lead a portfolio of products, including the preparation, filing, and approval of regulatory submissions to meet aggressive targets.Ensure compliance with applicable Health Canada, industry, and GSK codes and...


  • Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Key Responsibilities:Develop regulatory strategies to ensure timely product approvals with optimal labeling for products within therapy areas or for submissions within specialization areas.Accountable for a portfolio of products, including the preparation, filing, and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc.) to aggressive...

  • Regulatory Affairs

    6 days ago


    Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    About Alectra Utilities Inc.We are a leading utility company dedicated to delivering reliable and efficient services to our customers. Our team is passionate about making a positive impact on the community we serve.Salary Range$110,000 - $140,000 per annum, depending on experience.About the RoleWe are seeking an experienced Manager, Regulatory Affairs &...


  • Mississauga, Ontario, Canada Alectra Utilities Inc. Full time

    Job SummaryThe Manager, Regulatory Affairs & Compliance provides leadership and support to the Regulatory Affairs department including managing resources and processes to ensure compliance with all industry regulations impacting business operations. This position reviews and assesses emerging regulatory issues, industry standards, and OEB/MOE initiatives...


  • Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    At 837 GlaxoSmithKline Inc., we are seeking a highly skilled Regulatory Affairs Manager to join our Oncology team.About the RoleThis is an exciting opportunity for a seasoned regulatory professional to lead the development of regulatory strategies and ensure compliance with applicable Health Canada guidelines in the Oncology therapy area.Key...


  • Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Key Responsibilities:Develop regulatory strategies for rapid product approvals with optimal labeling in the Oncology therapy area.Lead a portfolio of products, ensuring compliance with Health Canada, industry, and GSK codes and guidelines.Build trust with Health Canada contacts to improve submission approval times and achieve competitive labeling.Communicate...


  • Mississauga, Ontario, Canada Brenntag Specialities Full time

    At Brenntag Specialities, we are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mississauga. This role is responsible for providing support to the organization in maintaining compliance and addressing needs related to new and existing business as they pertain to regulatory matters.Key ResponsibilitiesManage risk considering legal...


  • Mississauga, Ontario, Canada https:www.energyjobline.comsitemap Full time

    Job Title: Director of Sustainability and Regulatory AffairsFood, Health & Consumer Products of Canada (FHCP) is seeking a highly skilled Director of Sustainability and Regulatory Affairs to join its sustainability team. The successful candidate will be responsible for leading the development and implementation of sustainability strategies and policies that...


  • Mississauga, Ontario, Canada Brenntag Specialities Full time

    We are seeking a highly skilled Regulatory Affairs Manager to join our team at Brenntag Canada Inc.Job Summary:The successful candidate will be responsible for providing support to the organization in maintaining compliance and addressing needs related to new and existing business as they pertain to regulatory matters.This role will involve managing risk...


  • Mississauga, Ontario, Canada 837 GlaxoSmithKline Inc. Full time

    Key Responsibilities:Develop regulatory strategies to ensure timely product approvals with optimal labeling.Manage a portfolio of products, including preparation, filing, and approval of regulatory submissions to meet aggressive targets.Ensure compliance with applicable Health Canada, industry, and GSK codes and guidelines.Build relationships with Health...


  • Mississauga, Ontario, Canada Brenntag Specialities Full time

    Key Responsibilities:We are seeking a highly skilled Regulatory Affairs Manager to join our team in Mississauga. In this role, you will provide support to the organization in maintaining compliance and addressing needs related to new and existing business as they pertain to regulatory matters.Main Objectives:Manage risk considering legal compliance...