Associate Regulatory Affairs Director
1 month ago
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:
- 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 e.g., 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 e.g. 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 e.g., Artificial Intelligence and Machine Learning.
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-2024
Closing Date 20-Jun-2024
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr
-
Associate Regulatory Affairs Director, Vaccines
2 weeks ago
Mississauga, Ontario, Canada AstraZeneca 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 to make a real-life difference in patients' lives. That difference starts with...
-
Regulatory Affairs Associate
2 weeks ago
Mississauga, Canada Bayer Full time**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...
-
Regulatory Affairs Associate
2 weeks ago
Mississauga, Ontario, Canada Bayer Full timeAt Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where ,Health for all, Hunger for none' is no longer a dream, but a real possibility. We're doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and...
-
Director, Standards and Regulatory Affairs
6 days ago
Mississauga, Canada The Portage Group Full time**Position Summary** Our client, the **Heating, Refrigeration and Air Conditioning Institute of Canada** (HRAI) is seeking a Director of Standards and Regulatory Affairs. This position will oversee HRAI’ s manufacturers division and execute HRAI’s standards and regulatory affairs work. The role will have a significant focus on harmonization with U.S. &...
-
Associate Regulatory Affairs Director
2 weeks ago
Mississauga, Ontario, Canada AstraZeneca 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 individualized flexibility, our ways of working allow employees to balance...
-
Director - New Build Regulatory Affairs
3 weeks ago
Mississauga, Canada AtkinsRéalis Full time**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 the steward of Canadian CANDU nuclear technology. **Location - Mississauga,...
-
Regulatory Affairs Associate
4 days ago
Mississauga, Canada Amgen Full timeCareer Category Regulatory **Job Description**: HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is...
-
Associate Regulatory Affairs Director
2 weeks ago
Mississauga, Ontario, Canada AstraZeneca 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 individualized flexibility, our ways of working allow employees to balance...
-
Translational Regulatory Affairs Director
4 weeks ago
Mississauga, Canada AstraZeneca 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 individualized flexibility, our ways of working allow employees to balance...
-
Translational Regulatory Affairs Director
1 month ago
Mississauga, Canada AstraZeneca 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 individualized flexibility, our ways of working allow employees to balance...
-
Translational Regulatory Affairs Director
2 weeks ago
Mississauga, Ontario, Canada AstraZeneca Full timeAt AstraZeneca, we foster a collaborative culture that promotes knowledge-sharing, encourages ambitious thinking, and drives innovation - providing our employees with the opportunity to collaborate across teams, functions, and locations worldwide.Our ways of working prioritize individualized flexibility, allowing employees to balance personal and...
-
Translational Regulatory Affairs Director
6 days ago
Mississauga, Canada AstraZeneca 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 individualized flexibility, our ways of working allow employees to balance...
-
Regulatory Affairs Associate
4 days ago
Mississauga, Canada Amgen Full time**HOW MIGHT YOU DEFY IMAGINATION?** You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s...
-
Director - New Build Regulatory Affairs
2 weeks ago
Mississauga, Ontario, Canada AtkinsRéalis Full timeDirector - New Build Regulatory AffairsAtkinsRéalis 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 of Canadian CANDU nuclear technology.Location - Mississauga, ONYour role...
-
Regulatory Affairs Associate
2 weeks ago
Mississauga, Ontario, Canada Amgen Full timeCareer CategoryRegulatoryJob Description:HOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our...
-
Translational Regulatory Affairs Director
3 weeks ago
Mississauga, Canada AstraZeneca 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 individualized flexibility, our ways of working allow employees to balance...
-
Translational Regulatory Affairs Director
3 weeks ago
Mississauga, Canada AstraZeneca 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 individualized flexibility, our ways of working allow employees to balance...
-
Regulatory Affairs Associate
5 days ago
Mississauga, Canada Mint Pharmaceuticals Inc. Full timeJob description Canadian-owned and operated, Mint Pharmaceuticals Inc. ("Mint") is a leading manufacturer of high-quality and affordable generic pharmaceutical products. With a focus on consistent supply, innovation and exceptional customer service, Mint aims to deliver the highest value to patients across Canada. Mint has repeatedly been recognized as one...
-
Regulatory Affairs Associate
2 weeks ago
Mississauga, Ontario, Canada Amgen Full timeHOW MIGHT YOU DEFY IMAGINATION?You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world's leading...
-
CMC Regulatory Affairs Associate Director
2 weeks ago
Mississauga, Canada AstraZeneca Full timeWould you like to apply your Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs (RA) strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines for products in development? Then AstraZeneca might be the company for you! At AstraZeneca, we do this with the upmost integrity...