Cmc Regulatory Affairs Manager, Submission

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...

**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...

**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...

**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,...

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...

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,...

About GSKGSK is a global biopharma company that unites science, technology and talent to get ahead of disease together. Our purpose is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.Job DescriptionWe are seeking an experienced Regulatory Affairs Associate to join our team at 837...

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 regulatory submissions (NDSs, SNDSs, CTAs, NCs, etc) to aggressive targets. ...

Job DescriptionAbout UsWe are 837 GlaxoSmithKline Inc., a global biopharma company dedicated to unifying science, technology, and talent to get ahead of disease together. Our mission is to positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns.We prevent and treat disease with vaccines, specialty and...

Regulatory Affairs Project ManagerA Regulatory Project Manager at Juno Pharmaceuticals plays a crucial role in ensuring the successful growth and maintenance of the company's product portfolio. This position involves effectively preparing and managing assigned Regulatory Affairs projects to meet regulatory requirements and ensure compliance.Key...

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 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**: - **...

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 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’...

**Site Name**: Mississauga Milverton Drive **Posted Date**: Sep 19 2024 Are you ready to take on a pivotal role that shapes the future of healthcare in Canada? At GSK, we are on a mission to deliver innovative solutions that enhance patient care and improve health outcomes. In this role, you’ll collaborate with diverse local and global teams, bridging the...

Are 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...

**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...

Career 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...