Jobs
>
Mississauga

    Regulatory Affairs Project Director - Mississauga, Canada - AstraZeneca

    AstraZeneca
    AstraZeneca Mississauga, Canada

    3 weeks ago

    Default job background
    Full time
    Description

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

    Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

    Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we're taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

    The Regulatory Affairs Project Director (RAPD) is an experienced regulatory specialist with strong project management capabilities who takes on critical leadership roles for particularly complex and high priority global regulatory projects and / or major submissions. Typical capabilities for the RAPD are; to develop and maintain successful strategic and collaborative relationships, to proactively influence and negotiate across local and global teams and to independently resolve issues and drive accelerated delivery plans.

    Your responsibilities could include, but are not limited to:

  • Drive and lead delivery focused teams, , GRET (Global Regulatory Execution Team), RSDT (Regulatory Submission Delivery Team). Assume overall accountability for the planning, forecasting and reporting, utilising refined project and partner leadership skills, ensuring optimised delivery of regulatory activities to time and quality.
  • Be a core member of strategy teams, GRST (Global Regulatory Strategy Team) and RSST (Regulatory Submission Strategy Team), successfully collaborating with key stakeholders, challenging and contributing to ensure optimised delivery of regulatory strategy plans from Candidate Drug (CD) nomination through to submissions and approval to achieve critical achievements and scorecard goals.
  • Ensure all compliance activities for the project/product are completed and maintained.
  • Identify regulatory risks, opportunities and proactively develop mitigation strategies for operational regulatory activities, planned submissions, (with input from all team members).
  • Facilitate collaborator management and communication within Regulatory, cross functionally and across collaborations.

    • As a senior member of the RAM community, the RAPD will:

  • Be a recognised expert in the current regulatory environment. Understand the regulatory framework, including regional trends for various types of applications, procedures and documents, in both small and large molecules with a particular focus on planning, delivery and project management.
  • Be a recognized expert in the AZ Regulatory Operating Model and AZ Drug Development Process
  • Be a visible, approachable leader and role model for the whole RAM community.
  • Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of key regulatory activities, major submissions throughout the product's life cycle from a global and/or regional perspective.
  • May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
  • Be a role model for AZ Values & Behaviours: personally driven to improve standards across the business, drive and lead continuous improvement and knowledge sharing of standard process through coaching and mentoring across the RAM community.

    • Essential

  • University degree in science or a related subject area.
  • Extensive regulatory experience within the biopharmaceutical industry, or combined with experience at a health authority
  • Knowledge of regulatory procedures and legislation for drug development, throughout the product lifecycle
  • Managed first wave Marketing Application/Line Extension and/or LCM submissions, as a Submission Delivery Team Lead (SDTL).
  • Managed sophisticated regulatory results across projects/products.
  • Detailed knowledge of drug development.
  • Proven successful leadership and strong project management experience and skills.
  • Strong influencing, partner management and negotiating skills.
  • Proficiency with common project management tools and methodology.
  • Excellent written and verbal communication skills.
  • Team facilitation

    • Great People want to Work with us Find out why:

    Are you interested in working at AZ, apply today

    AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing .

    Date Posted

    14-May-2024

    Closing Date

    30-May-2024
  • CO_30 TC1 Bird Industrial Management Services Ltd.

    Project Director

    2 weeks ago

    CO_30 TC1 Bird Industrial Management Services Ltd. Mississauga, Canada Full time

    Project Director Where Greatness Grows · The greatest achievements in history are borne from the greatness within people – where human potential meets vision, and passion fuels evolution. Unlocking this potential is the most important thing we do at Bird. · As a leader in Ca ...

  • AstraZeneca

    Project Director

    2 weeks ago

    AstraZeneca Mississauga, Canada Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. · Recognizing the importance of ind ...

  • AstraZeneca

    Project Director

    3 weeks ago

    AstraZeneca Mississauga, Canada Full time

    Description · At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. · Recognizing the im ...

  • SNC-Lavalin

    Project Director, Information Management

    3 weeks ago

    SNC-Lavalin Mississauga, Canada Full time

    Job Description · Project Director, Information Management · AtkinsRéalis/CANDU Energy Inc. is a leading full-service nuclear technology company providing nuclear power reactors and nuclear products and services to customers worldwide. Our 1,200 highly skilled employees design ...

  • goeasy Ltd.

    Director, Project Delivery Office

    3 weeks ago

    goeasy Ltd. Mississauga, Canada

    Embark on a journey with one of Canada's fastest growing companies – welcome to goeasy We have been honored with recognitions such as Waterstone Canada's Most Admired Corporate Cultures , the 2022 Report on Business Women Lead Here , Report on Business for Canada's Top Growing ...

  • AstraZeneca GmbH

    Project Associate Director

    2 weeks ago

    AstraZeneca GmbH Mississauga, ON, Canada

    When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of bei ...

  • goeasy

    Director& Project Delivery Office

    3 weeks ago

    goeasy Mississauga, Canada

    Embark on a journey with one of Canada's fastest growing companies – welcome to goeasy We have been honored with recognitions such as Waterstone Canada's Most Admired Corporate Cultures, the 2022 Report on Business Women Lead Here, Report on Business for Canada's Top Growing Comp ...

  • AstraZeneca

    Project Director – Commercial Oncology

    3 weeks ago

    AstraZeneca Mississauga, Canada Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. · Recognizing the importance of ind ...

  • AstraZeneca

    GBS Project Services – Senior Director Project Services

    3 weeks ago

    AstraZeneca Mississauga, Canada Full time

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. · Recognizing the importance of ind ...

  • AstraZeneca

    Associate Director, Clinical Project Lead

    2 weeks ago

    AstraZeneca Mississauga, Canada Full time

    When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week ...

  • AtkinsRéalis

    Deputy Project Director, Tooling

    6 days ago

    AtkinsRéalis Mississauga, Canada

    Deputy Project Director, Tooling · AtkinsRéalis is one of Canada's largest private sector nuclear engineering groups. We have been providing a wide range of services to the nuclear industry in Canada and around the world since for more than 60 years. We are proud to be the stewar ...

  • AtkinsRéalis

    Project Director, Information Management

    2 weeks ago

    AtkinsRéalis Mississauga, Canada

    Job Description · Project Director, Information Management · AtkinsRéalis/CANDU Energy Inc. is a leading full-service nuclear technology company providing nuclear power reactors and nuclear products and services to customers worldwide. Our 1,200 highly skilled employees design an ...

  • AtkinsRéalis

    Project Director, Information Management

    1 week ago

    AtkinsRéalis Mississauga, Canada

    Project Director, Information Management AtkinsRéalis/CANDU Energy Inc. is a leading full-service nuclear technology company providing nuclear power reactors and nuclear products and services to customers worldwide. Our 1,200 highly skilled employees design and deliver state-of-t ...

  • AtkinsRéalis

    Deputy Project Director, Tooling

    1 day ago

    AtkinsRéalis Mississauga, Canada

    Job DescriptionDeputy Project Director, ToolingAtkinsRéalis is one of Canada's largest private sector nuclear engineering groups. We have been providing a wide range of services to the nuclear industry in Canada and around the world since for more than 60 years. We are proud to b ...

  • AtkinsRéalis

    Deputy Project Director, Tooling

    5 days ago

    AtkinsRéalis Mississauga, Canada

    Job Description · Deputy Project Director, Tooling · AtkinsRéalis is one of Canada's largest private sector nuclear engineering groups. We have been providing a wide range of services to the nuclear industry in Canada and around the world since for more than 60 years. We are prou ...

  • AtkinsRéalis

    Deputy Project Director, Tooling

    3 days ago

    AtkinsRéalis Mississauga, Canada

    Deputy Project Director, Tooling AtkinsRéalis is one of Canada's largest private sector nuclear engineering groups. We have been providing a wide range of services to the nuclear industry in Canada and around the world since for more than 60 years. We are proud to be the steward ...

  • goeasy

    Director, Project Delivery Office

    1 week ago

    goeasy Mississauga, Canada

    Embark on a journey with one of Canada's fastest growing companies - welcome to goeasy We have been honored with recognitions such as Waterstone Canada's Most Admired Corporate Cultures, the 2022 Report on Business Women Lead Here, Report on Business for Canada's Top Growing Comp ...

  • AtkinsRéalis

    Project Director, Information Management

    2 weeks ago

    AtkinsRéalis Mississauga, Canada

    Project Director, Information Management · AtkinsRéalis/CANDU Energy Inc. is a leading full-service nuclear technology company providing nuclear power reactors and nuclear products and services to customers worldwide. Our 1,200 highly skilled employees design and deliver state-of ...

  • AstraZeneca

    Regulatory Affairs Project Director

    2 weeks ago

    AstraZeneca Mississauga, Canada

    At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe. · Recognizing the importance of ind ...

  • McKesson's Corporate

    director, project management, fulltime

    1 week ago

    McKesson's Corporate Mississauga, ON, Canada Full time $115,100 - $191,900

    We may use Google Analytics to measure how you interact with our website in order to improve the user experience. Twitter · We may use other tracking technologies to collect and store personal information about your visit to our website. Server Logs – used to track the website t ...