Regulatory Affairs Manager, 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 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 bold, 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.

**Accountabilities**:
As a Regulatory Affairs Manager (RAM), you will be 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.

**Essential Skills/Experience**:

- B.S. Degree in Science or related field with 3 plus years of experience
- 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

**Desirable Skills/Experience**:

- Manage regulatory deliverables across projects/products
- Detailed knowledge of the drug development process

At AstraZeneca, we are a change maker on the world stage at an exciting frontier of medicine. This is backed by deep knowledge and experience in our field. Building on this, we lead the way into the future with energy and drive. We are helping to transform healthcare and build pandemic preparedness to protect against future health crises and to bring lasting immunity to people around the globe. We are committed to our central role in addressing pandemic and endemic diseases and ensuring our products continue to reach and benefit millions of people around the world.

We aim to provide long-lasting immunity to millions of people. Directly impact the lives of populations around the world, by turning our ambition to prevent disease into a reality. Here people always come first. We are making the changes that are needed to make access to medicines resilient and sustainable. Have the opportunity to create impact at scale and make a meaningful difference.

V&I

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