International Cmc Regulatory Affairs Associate

3 weeks ago


Mississauga, Canada AstraZeneca Full time

**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**:

- Assist in the preparation of international regulatory submissions, including formatting and compilation of submission documentation, and preparation of regulatory components.
- Ensure that publishing tools are in place and to perform publishing of the CMC sections in a timely manner.
- Support and delivery of submission ready packages to agreed timelines and management of information required.
- Ensure maintenance and filing of regulatory related documentation and track regulatory commitments, submission requests, and deliverables.
- Develop research skills relevant information, regulations, and guidance from different regulatory agencies.
- The role holder will train, guide and advise others, develop training and user support materials, e.g. job aids, training videos, e-learning
- Writing scripts and participating in system testing in support of system releases
- Interact with cross-functional groups and attend team meetings as necessary to support submission development and project coordination.
- Assist in the preparation of agendas, presentations, and other supporting materials for various meetings.
- Contribute to the development and improvement of related business processes.
- Review submission documentation for accuracy and compliance with applicable regulations and guidelines as required.
- Ensure the learning from own projects are shared with other colleagues/within the functions.

**Essential Requirements**
- Foundational / Associate degree in Science, Regulatory Sciences or Pharmacy
- Team working skills
- IT Skills
- Self-motivated
- 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.



  • Mississauga, Canada AstraZeneca Full time

    **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...


  • 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...


  • Mississauga, Canada Intrinsik Corp. Full time

    **Responsibilities include**: - Author CMC modules from source data for regulatory submissions for Health Canada and the US Food and Drug Administration. - Critical assessment of data and documents to identify gaps compared to regulatory requirements for Canada and the US. - Assist in the development of regulatory strategies for CMC and support with...


  • 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...


  • 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,...


  • Mississauga, Canada Mint Pharmaceuticals Inc. Full time

    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...


  • 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 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...


  • Mississauga, Canada Amgen Full time

    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...


  • 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...


  • 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 personal...


  • Mississauga, Canada Cerapie Pharma Inc. Full time

    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,...


  • Mississauga, Canada GSK Full time

    **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...


  • Mississauga, Canada Elanco Full time

    Education : 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...


  • 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 personal...


  • 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 personal...


  • Mississauga, Canada Seaford Pharmaceuticals Inc. Full time

    Under the direction of the department manager, the Regulatory Associate is responsible to carry out regulatory functions at Seaford Pharmaceuticals to ensure compliance with all regulatory requirements applicable to Seaford’s operations. This position is responsible to participate in the preparation and filing of regulatory submissions and correspondence...


  • Mississauga, Canada Medline Gruppe Full time

    Job Description - Regulatory Affairs Associate (QUA0101YP) Job Number: QUA0101YP Primary Location Value Proposition As a leading partner in healthcare, Medline Canada's sole purpose is Together Improving Care– this means being deeply committed to the health and well-being of our customers, employees, partners and our communities. We employ a diverse...


  • 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 personal...


  • Mississauga, Canada Boston Scientific Corporation Full time

    **Work mode**: **Onsite Location(s)**:Mississauga, ON, CA**Additional Locations**: Canada-ON-Mississauga; Canada-ON-Toronto**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing...