Regulatory Affairs Manager, Vaccines

3 weeks 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’ lives. That difference starts with you. We need people who share our passion for science and determination to meet patients’ needs around the world. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Does this match your skills and ambitions for the future? Then join us to be part of the development of innovative Vaccines and Immune Therapies for the prevention and treatment of **Infectious diseases.**

We are now looking for hard-working colleagues to join our Regulatory Project Management team as a **Regulatory Affairs Manager (RAM). **With us, you will have the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline.

**About the role**:
The Regulatory Affairs Manager (RAM) is a global regulatory specialist with project management capabilities responsible for leading / contributing to the end-to-end planning, coordination, and execution of assigned deliverables. The RAM manages delivery of submissions to time, quality, and in compliance with applicable regulations. The RAM is a contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory submissions and managing procedures through approval. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to Regulatory and cross-functional teams working globally to ensure the delivery of business objectives.

**Role & Responsibilities**:

- Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:

- Develop, execute and maintain submission delivery plans, submission content plans, support operational and compliance activities for assigned deliverables and proactively provide status updates to designated stakeholders.
- Lead and/or contribute to the planning, preparation and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
- Contribute to Submission delivery strategy
- Review documents for compliance with applicable internal policies and regulations(e.g study protocols, Periodic Safety Reports, etc.)
- Identify regulatory risks and communicate mitigations to Regulatory lead and cross functional teams.
- Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group.
- Contribute to process improvement to maintain and continuously improve regulatory consistency.
- Be responsible for general Regulatory compliance in assigned markets/regions and escalate any compliance issues.

**Requirements**:

- Relevant University Degree in Science or related field
- Regulatory experience within the biopharmaceutical industry, experience at a health authority, or other relevant experience.
- General knowledge of drug development
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
- Excellent written and verbal communication skills
- Cultural awareness
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
- Ability to work independently and as part of a team
- Influencing and stakeholder management skills
- Ability to analyze problems and recommend actions
- Continuous Improvement and knowledge sharing focused

**Desirables for the role**
- Led regulatory deliverables across projects/products
- Detailed knowledge of the drug development process

  • Regulatory Affairs Manager, Vaccines

    2 months ago

    Mississauga, Canada AstraZeneca Full time

    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’ lives. That difference starts...

  • Regulatory Affairs Manager

    2 weeks 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

    2 weeks 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’ lives. That...

  • Regulatory Affairs Manager, Vaccines

    2 weeks 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’ lives. That...

  • Associate Regulatory Affairs Director, Vaccines

    2 weeks ago

    Mississauga, Canada AstraZeneca Full time

    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 functional and global? At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts with...

  • Regulatory Affairs Associate

    3 weeks 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 Associate

    3 days ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: Jun 12 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...

  • Regulatory Affairs Manager, Oncology

    2 weeks ago

    Mississauga, Canada GSK Full time

    **Site Name**: Mississauga Milverton Drive **Posted Date**: May 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, specific in the Oncology therapy area, including...

  • Regulatory Affairs Manager

    1 month ago

    Mississauga, ON, Canada The Portage Group Full time

    Company 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

    6 days ago

    Mississauga, Canada Molinaro's Fine Italian Foods Full time

    Responsibilities including but not limited to: - Ensuring full compliance to all applicable legal regulations and food safety standards: BRC, HACCP, Canadian Food Inspection Agency, Food and Drug Administration, United States Department of Agriculture, Gluten-Free, Organic, Non-GMO, Halal etc. certifications - Support introduction of new ingredients,...

  • Regulatory Affairs Project Manager

    2 weeks ago

    Mississauga, Canada AstraZeneca Full time

    **_ Position Type: _**_Permanent, Full Time _ **Location**:Mississauga, Head Office (Hybrid, on average of 3 days/week in office) 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...

  • Regulatory Affairs Specialist

    4 weeks ago

    Mississauga, Canada M&M Food Market Full time

    We are looking for our next Regulatory Affairs Specialist. Could it be you? Reporting to the Regulatory Affairs Manager, the Specialist, Regulatory Affairs ensures effective implementation and management of the regulatory affairs systems, programs and procedures for the business. You'll advise and

  • Regulatory Affairs Manager, Oncology

    2 weeks ago

    Mississauga, Canada 837 GlaxoSmithKline Inc. Full time

    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, specific in the Oncology therapy area, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs,...

  • Regulatory Affairs Manager, Oncology

    2 weeks ago

    Mississauga, Canada 837 GlaxoSmithKline Inc. Full time

    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, specific in the Oncology therapy area, including the preparation, filing and approval of regulatory submissions (NDSs, SNDSs,...

  • Regulatory Affairs Manager

    3 weeks 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 personal...

  • Regulatory Affairs Manager

    2 days 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 personal...

  • Regulatory Affairs Associate

    2 days ago

    Mississauga, Canada GlaxoSmithKline Full time

    Site Name: Mississauga Milverton DrivePosted Date: Jun 12 2024Key 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...

  • Regulatory Affairs Associate

    2 days ago

    Mississauga, Canada GlaxoSmithKline Full time

    Site Name: Mississauga Milverton DrivePosted Date: Jun 12 2024Key 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...

  • Regulatory Affairs Manager

    2 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Regulatory Affairs Manager, CVRM (Cardiovascular, Renal and Metabolism) Hybrid Work- on average 3 days/week from office Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and...

  • Regulatory Affairs Manager

    2 weeks ago

    Mississauga, Canada AstraZeneca Full time

    Regulatory Affairs Manager, CVRM (Cardiovascular, Renal and Metabolism) Hybrid Work- on average 3 days/week from office Minimum 1 day from our Mississauga office and 2 days from our Mississauga or Downtown office At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and...