- Lead and/or contribute to the planning, preparation, and delivery of submissions of varying complexity throughout the product's life cycle from either a global and/or regional perspective.
- Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
- Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including submission delivery strategy of all dossiers and all application types per market and/or region and review of documents , response documents, study protocols, Periodic Safety Reports and provide regulatory input.
- Lead multi-disciplinary project teams.
- Support operational and compliance activities for assigned regulatory tasks.
- Provide coaching, mentoring and knowledge sharing within the regulatory skill group.
- Contribute to process improvement.
- Identify regulatory risks and propose mitigations to appropriate member of cross functional teams.
- Relevant University Degree in Science or related field.
- Extensive Regulatory experience (3+ years) within the biopharmaceutical industry, or at a Health Authority, or other proven experience.
- Thorough drug development knowledge.
- Strong Project management skills including tools MS Project.
- Excellent written and verbal communication skills.
- Leadership skills, including experience leading multi-disciplinary project teams.
- Knowledge of the Respiratory & Immunology therapy area.
- Managed first wave Marketing Applications and/or Life Cycle Management submissions.
- Managed complex regulatory deliverables across projects/products.
- Veeva Vault experience.
- Demonstrate a high ability to use digital tools and solutions, and have a broad working knowledge of emerging technologies , Artificial Intelligence and Machine Learning.
-
Translational Regulatory Affairs Director
3 weeks ago
AstraZeneca Mississauga, Canada Full timeAt 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 ...
-
Regulatory Affairs Project Director
3 weeks ago
AstraZeneca Mississauga, Canada Full timeAt 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 ...
-
Translational Regulatory Affairs Director
1 week ago
AstraZeneca Mississauga, CanadaAt 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 ...
-
Associate Regulatory Affairs Director, Vaccines
3 weeks ago
AstraZeneca Mississauga, Canada Full timeAre you passionate about science and experienced within drug development and regulatory affairs? Would you like to combine your project management skills with your experience of working cross functional and global? · At AstraZeneca, we are driven by innovation and our dedication ...
-
Regulatory Affairs Project Director
2 weeks ago
AstraZeneca Mississauga, CanadaAt 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 ...
-
Director of Regulatory Affairs and Quality
3 weeks ago
Trexo Robotics Mississauga, ON, CanadaTrexo Robotics (Y Combinator Company) is enabling mobility by building powered wearable robots. Our first product is a robot for children with movement disorders such as Cerebral Palsy, and it allows kids to walk, in many cases, for the first time in their lives. We are constantl ...
-
Director of Regulatory Affairs and Quality
2 weeks ago
GlaxoSmithKline Mississauga, ON, CanadaSite Name: Mississauga Milverton Drive · Develops regulatory strategies for rapid approvals with optimal labelling for products within therapy or for submissions within specialization area · Accountable for a portfolio of products, specific in the Oncology therapy area, includi ...
-
Director of Regulatory Affairs and Quality
3 weeks ago
GlaxoSmithKline Mississauga, ON, CanadaSite Name: Mississauga Milverton Drive · Please note: this is a month contract · Hybrid role from our Mississauga office. · Responsible for the effective functioning of the internal control framework including elements such as training, written standards, management monitoring ...
-
AstraZeneca Mississauga, Canada Full timeDo you have leadership skills and an in depth knowledge within Regulatory Affairs? Do you want to work on innovative projects of importance for our early Respiratory and Immunology portfolio? · At AstraZeneca, we aspire to be pioneers in science, leading in our disease areas a ...
-
Director - New Build Regulatory Affairs
3 days ago
AtkinsRéalis Mississauga, ON, CanadaJob Description · Director - New Build Regulatory Affairs · 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 ...
-
Director - New Build Regulatory Affairs
1 week ago
AtkinsRéalis Mississauga, CanadaDirector - New Build Regulatory Affairs · 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 ...
-
Turkey Farmers of Canada Mississauga, CanadaThe Turkey Farmers of Canada (TFC) is a national industry association representing the interests of turkey producers, and the sector generally. TFC is dedicated to fostering growth, sustainability, and innovation within the Canadian turkey industry. With a commitment to excellenc ...
-
Alexion Pharmaceuticals Mississauga, Canada Full timeAlexion is seeking a Director, Head of Global Medical Affairs Business Operations to bring strategic leadership and operational excellence to our Global Medical Affairs (GMA) teams. This is a role for a visionary leader who thrives on coordination and collaboration across multipl ...
-
Associate Regulatory Affairs Director
3 weeks ago
AstraZeneca Mississauga, CanadaAt 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 ...
-
Director/Manager Regulatory Affairs
3 weeks ago
AstraZeneca Mississauga, ON, CanadaAt 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 in ...
-
Alexion Pharmaceuticals Mississauga, CanadaLocation: Mississauga, Canada Job reference: R Date posted: 06/03/2024 · Alexionis seeking aDirector, Head of Global Medical Affairs Business Operationsto bring strategic leadership and operational excellence to our Global Medical Affairs (GMA) teams. This is a role for a visiona ...
-
AstraZeneca GmbH Mississauga, CanadaAlexionis seeking aDirector, Head of Global Medical Affairs Business Operationsto bring strategic leadership and operational excellence to our Global Medical Affairs (GMA) teams. This is a role for a visionary leader who thrives on coordination and collaboration across multiple f ...
-
Director, Regulatory Affairs
2 weeks ago
Parexel Ontario, Canada Full timeWhen our values align, there's no limit to what we can achieve. · Great opportunity to use your regulatory expertise and lead a truly exceptional team · As a Director, Regulatory Affairs , you will use your expertise to lead and mentor a team of high-performing Regulatory Aff ...
-
Director - New Build Regulatory Affairs
1 week ago
AtkinsRéalis Mississauga, Canada**Director - New Build Regulatory Affairs** · 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 ...
-
Director, Public Affairs
3 weeks ago
GS1 Canada Old Toronto, CanadaDirector, Public Affairs - ESG · Application Deadline: 20 June 2024 · Department: Public Affairs · Employment Type: Contract · Location: Toronto, ON · Reporting To: Angela Hawkins · Description · GS1 Canada is a neutral, not-for-profit organization that develops and maintains glo ...
Associate Regulatory Affairs Director - Mississauga, Canada - AstraZeneca
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.
What you'll do
Working in the role as an Associate Regulatory Affairs Director (ARAD), you will lead the end-to-end planning, coordination, and execution of assigned regulatory procedures and submissions. With your knowledge and strong project management skills, you will be a key contributor to the regulatory submission strategy, identifying submission risks and opportunities, while leading complex regulatory applications and managing procedures through approval.
In this role you will have a unique opportunity to work in cross functional teams, with all phases of drug development across geographic regions making sure that the regulatory project delivery and process improvements are in line with business priorities.
Your main accountabilities/responsibilities:
Essential for the role
Desirable for the role
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
22-May-2024Closing Date
20-Jun-2024
Associate Regulatory Affairs Director professionals in Mississauga
-
CityVP Manjit
PURPOSE : ALL OPINIONS EXPRESSED AT beBee ARE MY OWN · BeBee is now the hub of my exploration.. · It ...
-
Yanni Fung
Communications & Public Relations Intern
-
Vladislav Kondrashov
Physicist PhD, SR&ED expert
-
Sharifamo Odinamamadova
UofT Financial Economics & Statistics Student
-
Ruchika Balchandani
L&D/Project Mgmt/Employee Engagement/Training
-
wanjiku kiarie
Administrative Assistant/ CSR & HR Professional