Regulatory Affairs Project Manager Cmc
7 months ago
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 Manager, CMC will provide leadership on regulatory CMC matters to deliver efficient Health Canada approvals (time and quality), maintain compliance, and improve a product’s potential and lifecycle in the Canadian marketplace. Actively support the Regulatory Affairs department to maximize efficiency, performance and productivity. Role holder has an understanding of current regulatory CMC/DEL/Environmental regulations and requirements.
**Responsibilities**:
- Lead in the development and implementation of CMC, Establishment License (EL) and Environmental (NSN) submission and risk management strategies which will facilitate the review process with a strive to deliver Health Canada approvals in support of business objectives.
- Own the planning and execution of all activities associated with CMC-related Health Canada meetings including the development of supporting briefing materials and completion of post-meeting activities.
- Review chemistry and manufacturing documentation for compliance vs AZ standards, Health Canada regulations and ICH guidelines. Convey recommendations to management.
- Prepare and submit regulatory files (NDSs, SNDSs, NCs, Level III Changes, DEL and NSN submissions) in adherence with the Food and Drugs, Medical Device and Environmental Regulations, as appropriate, for submission to the Pharmaceutical Drugs Directorate (PDD), Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Environmental Assessment Unit and Health Products and Food Branch Inspectorate (HPFBI), Health Canada.
- Facilitate submission approvals through effective negotiation and communication with PDD, BRDD, and HPFBI.
- Maintain registration compliance for assigned projects to support ongoing manufacture and/or marketing of products in Canada.
- Lead or support therapeutic area projects/submissions as directed by Manager.
- Develop, foster and maintain positive relationships with all stakeholders involved in the lifecycle management of our brands.
- Help supervise changes to Regulatory environment (regulations, guidelines, policies, etc.) as advised by Manager.
- Conduct activities and interactions consistent with Company values and in compliance with the Code of Conduct and supporting Policies and Standards relevant to your role. Complete all required training on the AZ Code of Conduct and supporting Policies and Standards on time. Report potential issues of non-compliance.
**Essential**:
- B.Sc. or equivalent in a related (chemistry, health science) discipline. Advanced degree (M.Sc.) considered an asset as well as experience with Biologic and Establishment Licenses and drug product manufacturing.
- Previous experience in Regulatory Affairs mandatory.
- Current knowledge of cGXP’s (in particular cGMP, cGLP, cGCP), CMC Regulatory and ICH guidelines.
- Able to balance and progress multiple projects across all therapeutic areas.
- Proficient in the use of Microsoft Office and Veeva Vault platforms.
- Problem-solving ability and innovative thinking.
- Attention to detail, balanced with understanding of business objectives.
**Desirable**:
- Therapeutic area, product and brand knowledge
- Knowledge of AstraZeneca global and local policies and procedures
- Knowledge of international regulatory activities and trends
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
-
Cmc Regulatory Affairs Manager- Submission
3 weeks ago
Mississauga, Canada AstraZeneca Full timeJoin AstraZeneca, a place built on innovation and creativity. Where different views and perspectives are encouraged and valued. An environment that champions inclusion, and teams that reflect the diversity of the communities that we serve. We are looking for a **Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs Associate** to join us on a...
-
Cmc Regulatory Affairs Manager, Submission
3 months ago
Mississauga, Canada AstraZeneca 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 individualized flexibility, our ways of working allow employees to balance...
-
Cmc Regulatory Affairs Associate I
4 days ago
Mississauga, Canada Gilead Sciences Full timeGilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams. For Current Gilead Employees and...
-
Cmc Regulatory Affairs Associate I
1 day ago
Mississauga, Canada Gilead Sciences, Inc. Full time**Responsibilities**: Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams. For Current...
-
Regulatory Affairs Cmc Manager
3 months ago
Mississauga, Canada GSK Full time**Site Name**: Mississauga Milverton Drive **Posted Date**: Oct 31 2024 **Key Accountabilities/Responsibilities**: - 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, including the preparation, filing and approval of...
-
Cmc Regulatory Affairs Director and Team Manager
4 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,...
-
Cmc Ra Reg Manager Submission Excellence and
7 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 personal...
-
Regulatory Affairs Manager
6 days 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...
-
Cmc Document Specialist
4 days ago
Mississauga, Canada Biolab Pharma Ltd. Full time**Title: CMC Document Specialist** **Reports to: Junior Manager R&D Quality Assurance and Technical Documentation** The CMC Documentation Specialist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by supporting the documentation activities for...
-
Associate, Regulatory Affairs
2 weeks ago
Mississauga, Canada Natco Pharma (Canada) Inc. Full time**Associate, Regulatory Affairs** Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated generic pharmaceutical company focused on research & development, and the manufacturing of active pharmaceutical ingredients (API) and finished drug product formulations. The Regulatory Affairs department is responsible...
-
Regulatory Affairs Project Manager
5 hours 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 personal...
-
Regulatory Affairs Specialist
2 months ago
Mississauga, Canada Cerapie Pharma Inc. Full timeThe **Regulatory Affairs Specialist** is responsible for compiling, submitting, and maintaining drug product registrations for the US and Canada and assisting with global drug product registrations. **Principal Duties and Responsibilities**: - Prepare and/or review submissions to Health Canada and FDA for a variety of dosage forms (solid oral, liquids,...
-
Regulatory Affairs Director
7 months 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...
-
Associate, Regulatory Affairs
7 days ago
Mississauga, Canada Natco Pharma (Canada) Inc. Full time**About Natco**: Natco Pharma (Canada) Inc. is the Canadian subsidiary of Natco Pharma Limited, a vertically integrated pharmaceutical company focused on R&D and the manufacturing of drug products. We are a trusted supplier of medicines evidenced from our work with the world’s largest drug companies. Natco is renowned for trust, reliability, and commitment...
-
Mississauga, Canada Biolab Pharma Ltd. Full time**Title: CMC Document Specialist Formulation Development** **Reports to: Manager Formulation Development** The formulation development CMC Documentation Specialist supports the development of new pharmaceutical dosage forms in addition to improving existing products and procedures. These activities will be achieved by supporting the documentation...
-
Mississauga, Canada Juno Pharmaceuticals Full timeNEW JOB POSTING: Regulatory Affairs Project ManagerPosition 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 environment.Responsibilities:Effectively...
-
Regulatory Affairs Strategy Director
2 months ago
Mississauga, Canada AstraZeneca Full timeAre you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on! **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...
-
Regulatory Affairs Manager
7 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 personal...
-
Regulatory Affairs Associate
7 months 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 Manager, Vaccines
8 months ago
Mississauga, Canada AstraZeneca Full time**About us**: Are 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 functionally and globally? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’...