Regulatory Affairs Analyst
CDMX
- AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies._
At AstraZeneca, we believe in the potential of our people and you'll develop beyond what you thought possible. We need great people who share our passion for science and have the drive and determination to meet the needs of patients around the world. With more than 59,000 employees in over 100 countries worldwide, you could be part of delivering life-changing medicines that improve patients' lives and benefit society globally.
Be trusted and empowered to be the best you can be. Here we thrive in our inclusive, diverse and bold environment. We draw on our diverse knowledge to take smart risks and uncover new and creative ways to deliver better for our patients and our business.
**Who we are**
We are all compassionate team players and driven achievers, always ready to step up.
**What we do**
We play a key role in making sure our transformative science born in labs will be transformed into real value for patients.
**How we do it**
We believe that by asking questions and trying new things, we can drive innovation and develop modern approaches.
Plan and execute regulatory activities in order to support AstraZeneca operations, projects and objectives while maintaining in compliance with company policies, local regulations and quality and ethical standards.
Typical Accountabilities:
- Creation and updating of the local Product Information (IPP's) for submission to regulatory agency
- Management and coordination of translations
- Update and maintenance of the product registration dossier by each product
- Guarantee the timely updating of all the databases and corporate tools of the product registrations.
- Downloading information from the global systems dossiers
- Preparation, assembly and print of dossiers to support all submission to the regulatory agency
- Final review of texts projects of the artworks to avoid any error
- Review and work according to SOPs
Education, Qualifications, Skills and Experience:
- 2 years of experience in regulatory affairs or quality within the pharma industry.
- Basic knowledge of health care regulations, laws and standards
- Analytical, written and oral communications skills
- Ability to work effectively in a team
**_ 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._
**_
So, what's next? _**
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it's yours._
**Where can I find out more?**
Our Social Media, Follow AstraZeneca on LinkedIn
Follow AstraZeneca on Facebook
Follow AstraZeneca on Instagram