Regulatory Affairs Director
5 months ago
At **AstraZeneca**, we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within **Oncology Regulatory Science Strategy and Excellence** (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our ground-breaking pipeline and the business to get medicines to patients as efficiently and optimally as possible.
**AstraZeneca in 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 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.
**Our Position**
**The Regulatory Affairs Director** (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.
**What you'll do**:
- Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority (HA) interactions, label discussions, and securing approvals.
- Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with insightful labeling that is identified by the business, markets and patients.
- Craft the forward-thinking health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
- Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Mentor, empower and provide performance feedback to members of your GRST.
- Deliver sophisticated regulatory projects including an assessment of risks and mitigations, new insights, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling.
- Own discussions with health authorities and initiate and deliver key regulatory documents.
- Plan and build the global dossier and core prescribing information including product maintenance, supply and compliance activities.
- Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
**Minimum Qualifications**:
- Bachelor's degree in a science related field with at least 3 years of Regulatory strategy or related knowledge/experience.
- A solid understanding of regulatory affairs within at least one therapeutic area in both early and late development, preferably oncology (small molecules & biologics)
- Previous experience of regulatory drug development or equivalent, and experience with major HA interactions.
- Demonstrated competencies of critical thinking, strategic influencing, risk evaluation, innovation, initiative, leadership skills and strong communication skills.
**Great People want to Work with us Find out why**:
- GTAA Top Employer Award for 9 years
- Learn about our culture
- Learn more about working with us in Canada
- View our YouTube channel
-
Mississauga, Ontario, Canada https:www.energyjobline.comsitemap Full timeJob 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 Odgers Berndtson Full timeDirector of Sustainability Job DescriptionFood, Health & Consumer Products of Canada (FHCP) is seeking a highly skilled Director of Sustainability to join its proactive team. As a leader in the department, this role will be directly engaged in federal, provincial, and territorial regulatory and policy development, as well as industry initiatives to influence...
-
Mississauga, Ontario, Canada Odgers Berndtson Full timeDirector of Sustainability Job DescriptionFood, Health & Consumer Products of Canada (FHCP) is seeking a highly skilled Director of Sustainability to join its proactive team. As a leader in the department, this role will be directly engaged in federal, provincial, and territorial regulatory and policy development, as well as industry initiatives to influence...
-
Director - New Build Regulatory Affairs
5 months 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,...
-
Translational Regulatory Affairs Director
5 months 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...
-
Cmc Regulatory Affairs Director and Team Manager
2 months ago
Mississauga, Canada AstraZeneca Full time**Job Title**: CMC Regulatory Affairs Director and Team Manager Submission Excellence & Project Management **Location**: Mississauga, ON 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,...
-
Director, Standards and Regulatory Affairs
5 months 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. &...
-
Mississauga, Ontario, Canada Citi Full timeJob Title: Senior Quality Assurance and Regulatory Affairs DirectorCiti is seeking a highly experienced Senior Quality Assurance and Regulatory Affairs Director to join our Internal Audit team. As a key member of our organization, you will be responsible for directing the timely delivery of complex, high-quality assurance and audit reports for a portfolio of...
-
Mississauga, Ontario, Canada Citi Full timeJob Title: Senior Quality Assurance and Regulatory Affairs DirectorCiti is seeking a highly experienced Senior Quality Assurance and Regulatory Affairs Director to join our Internal Audit team. As a key member of our organization, you will be responsible for directing the timely delivery of complex, high-quality assurance and audit reports for a portfolio of...
-
Regulatory Affairs Consultant
1 month ago
Mississauga, Ontario, Canada Q&C Full timeJob Title: Lead Regulatory Affairs ConsultantQ&C is seeking a highly skilled and experienced Lead Regulatory Affairs Consultant to join our team. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support to our clients in the pharmaceutical industry.Key Responsibilities:Develop and implement...
-
Regulatory Affairs Consultant
1 month ago
Mississauga, Ontario, Canada Q&C Full timeJob Title: Lead Regulatory Affairs ConsultantQ&C is seeking a highly skilled and experienced Lead Regulatory Affairs Consultant to join our team. As a key member of our regulatory affairs team, you will be responsible for providing strategic guidance and support to our clients in the pharmaceutical industry.Key Responsibilities:Develop and implement...
-
Regulatory Affairs Manager
3 weeks ago
Mississauga, Ontario, Canada Alectra Utilities Inc. Full timeRegulatory 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...
-
Regulatory Affairs Manager
1 month ago
Mississauga, Ontario, Canada Alectra Utilities Inc. Full timeRegulatory Affairs ManagerAbout the RoleAlectra Utilities Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing leadership and support to ensure compliance with industry regulations and government policies.Key ResponsibilitiesLead and manage...
-
Regulatory Affairs Manager
1 month ago
Mississauga, Ontario, Canada Alectra Utilities Inc. Full timeRegulatory Affairs ManagerAbout the RoleAlectra Utilities Inc. is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing leadership and support to ensure compliance with industry regulations and government policies.Key ResponsibilitiesLead and manage...
-
Regulatory Affairs Intern
5 months ago
Mississauga, Canada GE Healthcare Full time**Job Description Summary**: The Regulatory Affairs Intern will be involved in Premarket and Compliance duties. They will work with a team of Regulatory Affairs professionals and provide support to ensure GEHC establishes and implements best practice processes and procedures in premarket support. **Key responsibilities/essential functions include**: - **...
-
Regulatory Affairs Specialist
5 months ago
Mississauga, Canada Cardinal Health Full timeCardinal Health Canada, with over 1300 employees nationwide, is an essential link in the Canadian healthcare supply chain, providing over 70,000 products to healthcare facilities and medical professionals across the country. Cardinal Health Canada is currently seeking a Regulatory Affairs Specialist to join the Regulatory Affairs and Quality Assurance team...
-
Regulatory Affairs Associate
5 months 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...
-
Regulatory Affairs Manager
4 weeks ago
Mississauga, Ontario, Canada Alectra Utilities Inc. Full timeJob Title: Manager, Regulatory Affairs & ComplianceAbout the Role:The Manager, Regulatory Affairs & Compliance will provide leadership and support to the Regulatory Affairs department, ensuring compliance with industry regulations and providing advice on necessary actions.Key Responsibilities:Lead and manage the timely and accurate reporting of OEB regulated...
-
Regulatory Affairs Manager
4 weeks ago
Mississauga, Ontario, Canada Alectra Utilities Inc. Full timeJob Title: Manager, Regulatory Affairs & ComplianceAbout the Role:The Manager, Regulatory Affairs & Compliance will provide leadership and support to the Regulatory Affairs department, ensuring compliance with industry regulations and providing advice on necessary actions.Key Responsibilities:Lead and manage the timely and accurate reporting of OEB regulated...
-
Regulatory Affairs Associate
5 months 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...
