Cmc Ra Reg Manager Submission Excellence and

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...

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...

**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...

**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,...

**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...

**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...

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...

**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...

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._ **Summary of the...

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...

**Scope/Purpose**: **Responsibilities** - This job description is not intended to be an exhaustive list of duties and may be amended by the Company at any time. _ - Assist with electronic submissions for the EU and UK - Upload all submission elements into the electronic submission portal and fill out all required fields - Track the status of all...

**Quality Assurance & Regulatory Affairs Specialist position** HANSAmed is a specialty Cell-Tissue-Organs, Medical Device, and pharmaceutical distributor. We are committed to providing exceptional service and brand awareness to thousands of hospitals, dental and oral surgery clinics that we serve in Canada, the United States and around the world. HANSAmed...

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...

**Job Description / Roles and Responsibilities for Job Title**: **1)** Maintain an excellent knowledge of clinical trials/clinical research and a thorough understanding of industry regulatory requirements **2)** Stay current on regulatory updates and issue regular communications bulletins within the organization **4)** Communication with the regulatory...

Prepares/executes global/regional regulatory tactical submission plans on allocated projects/products that implement the agreed regulatory strategy to develop and maintain products. Generates/project manages delivery, to time/quality of submissions. Demonstrates in depth knowledge of Regulatory compliances and submissions. Develops and builds good...

**Responsibilities**: - Consistently develop, execute and deliver audit reports in a timely manner, in accordance with Internal Audit and Regulatory standards - Review and approve the Business Monitoring Quarterly summary and serve as lead reviewer for all reviews - Collaborate with teams across the business and determine impact on overall control...

Key Responsibilities:Develop regulatory strategies to ensure timely product approvals with optimal labeling for products within therapy areas or for submissions within specialization areas.Accountable for a portfolio of products, including the preparation, filing, and approval of regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc.) to aggressive...

Job 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...

The **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,...

Summary of the Group: Biopharmaceutical Development (BPD) develops the broad range of scientifically-advanced, high-quality processes and methodologies required for the manufacture and supply of clinical products across the AstraZeneca’s biologics portfolio. CMC Project Management function within BPD plays a meaningful role in advancement of projects...