International Cmc Regulatory Affairs Manager
2 weeks ago
**Job Description**:
**About AstraZeneca**
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
**Chemistry, Manufacturing, and Controls (CMC)**
Our Chemistry, Manufacturing, and Controls (CMC) Regulatory function spans across the product lifecycle and are responsible for the regulatory strategy relating to the development, manufacture and testing of all of our medicines.
With our expertise we interpret, anticipate and shape global Health Authority expectations to build insightful CMC and Device Regulatory Strategies.
**What you will do**:
The role holders effectively manage the delivery, compilation and production of Chemistry, Manufacturing and Control (CMC) documentation for designated product ranges to deliver the needs for the international region and filings according to accelerated wave plans. They project manage global CMC regulatory submissions ensuring that project activities and documentation are delivered to the required standards across the product Lifecyle. The role holder will contribute and lead the regulatory CMC components of business-related projects. They will have effective levels of interactive communication with stakeholders and project team members to ensure relevant timelines and regulatory commitments are communicated.
- Accountable for delivering “submission ready” international CMC modules to internal and external regulatory stakeholders in compliance with relevant AstraZeneca systems and procedures and ensuring submission quality.
- Documenting maintenance and communication of Health Authority approval status.
- Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of CMC submissions.
- Project management expertise with the ability to adapt to changing situations to ensure on time delivery.
- Ensure the learning from own projects are shared with other colleagues/within the functions.
- Participation in regulatory execution and delivery meetings and communicate and provide relevant updates to the international CMC team.
- Contribute to business process optimisation activities to reduce waste and ensure efficiency.
- Continually evolve and develop the regulatory expertise through proactive recording and communications of Health Authority interactions, responses and commitments.
**Essential Requirements**
- Bachelors degree in Science, Regulatory Sciences or Pharmacy
- Experience in Regulatory / Drug development (Industry or Health Authority)
- Breadth of knowledge of manufacturing, project, technical and regulatory management.
- IT Skills
- Stakeholder & Project management
- Professional capabilities: Regulatory knowledge
**Why AstraZeneca?**
At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.
-
Regulatory Affairs Intern
5 days 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 Director
4 weeks ago
Mississauga, Canada AstraZeneca Full timeAt **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 Affairs Administrative Intern
7 days ago
Mississauga, Canada Elanco Full timeEducation : EQUIVALENTEXPERIENCE **At Elanco (NYSE: ELAN) - it all starts with animals!** **As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to...
-
Regulatory Affairs Manager
4 days ago
Mississauga, Canada The Portage Group Full timeCompany Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association...
-
Regulatory Affairs Manager
5 days ago
Mississauga, Canada The Portage Group Full timeCompany Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association...
-
Regulatory Affairs Manager
4 days ago
Mississauga, Canada The Portage Group Full timeCompany DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...
-
Regulatory Affairs Manager
2 days ago
Mississauga, Canada The Portage Group Full timeCompany Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...
-
Regulatory Affairs Manager
2 days ago
Mississauga, Canada The Portage Group Full timeCompany DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...
-
Regulatory Affairs Manager
5 days ago
Mississauga, Canada The Portage Group Full timeCompany DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...
-
Regulatory Affairs Manager
5 days ago
Mississauga, Canada The Portage Group Full timeCompany DescriptionThe Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client.Position...
-
Regulatory Affairs Manager
3 days ago
Mississauga, Canada The Portage Group Full timeCompany Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client . Position...
-
Global Scientific and Regulatory Affairs Intern
4 weeks ago
Mississauga, Canada Ingredion Canada Corporation Full time**The major responsibilities of this role include**: Design and lead a special project as assigned. This may include a deep dive of one of Health Canada consultations and/or a comparison between current and proposed regulatory updates. Support the team in regulatory and technical presentations for the business and create training material for the G2M...
-
Regulatory Affairs Manager
5 days ago
Mississauga, ON, Canada The Portage Group Full timeCompany Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client. Position...
-
Regulatory Affairs Manager
5 days ago
Mississauga, ON, Canada The Portage Group Full timeCompany Description The Portage Group is a national consulting firm providing pragmatic and future-focused consulting solutions to associations, not-for-profit, and regulatory organizations. Our areas of expertise include research, strategy, executive search, and general management consulting. This position is with an industry association client. Position...
-
Manager, Regulatory Affairs
3 days ago
Mississauga, Canada Trillium Health Partners Full time**Job Description**: **Position**:Manager, Regulatory Affairs **Status**:Full Time **Department**:Professional Practice **Posted Date**:Monday July 10th, 2023 - July 31st, 2023 11:59 PM EDT **Salary Band**: $96,200 - $144,350 (salary band placement commensurate with experience) *** A New Kind of Health Care for a Healthier Community. That’s our...
-
Quality Assurance
6 days ago
Mississauga, Canada Radiant Full timeRadiant offers a complete range of industry-leading transportation and warehousing solutions to businesses around the globe by leveraging our extensive network of carrier partners across all modes. Radiant provides customized logistics solutions that create value and increase profitability for our customers. Radiant Canada is a learning environment in which...
-
Regulatory Affairs Specialist
4 weeks ago
Mississauga, Canada Profound Medical Full timeOur mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic,...
-
Mississauga, Canada Juno Pharmaceuticals Full timeNEW JOB POSTING: Regulatory Affairs Project Manager Regulatory Affairs Project Manager Position Overview: A Regulatory Project Manager at Juno Pharmaceuticals effectively prepares and manages assigned Regulatory Affairs projects to ensure successful growth and maintenance of the Juno product portfolio in a fast paced, sociable, upbeat and rewarding...
-
Mississauga, Canada Juno Pharmaceuticals Full timeNEW JOB POSTING: Regulatory Affairs Project Manager Regulatory Affairs Project Manager Position Overview: A Regulatory Project Manager at Juno Pharmaceuticals effectively prepares and manages assigned Regulatory Affairs projects to ensure successful growth and maintenance of the Juno product portfolio in a fast paced, sociable, upbeat and rewarding...
-
Mississauga, Canada Juno Pharmaceuticals Full timeNEW JOB POSTING: Regulatory Affairs Project Manager Regulatory Affairs Project Manager Position Overview: A Regulatory Project Manager at Juno Pharmaceuticals effectively prepares and manages assigned Regulatory Affairs projects to ensure successful growth and maintenance of the Juno product portfolio in a fast paced, sociable, upbeat and rewarding...
