Analista de Asuntos Regulatorios

Regulatory Affairs Analyst

Preferred candidate identified

Typical Accountabilities:

• Supports all activities related to product registration and maintenance in compliance with all local and global codes standards and procedures.
• Assists with the compilation and submission of regulatory dossiers approval procedures and regulatory maintenance including the maintenance of regulatory databases.
• Monitors the variation approval process implementing regulatory activities as required by law and by AZ.
• Maintains the products regulatory/technical dossier and tracks submissions/achievements ensuring compliance with requirements for audits or inspections.
• Interacts with the local IT/IS function and regulatory leads in the development implementation and maintenance of regulatory tools.
• Has personal responsibility for fostering a culture of courageous leadership creativity and collaboration.
• Responsible for activities related to the quality management system.
• Maintains GMP CPP and PoA certificates used for regulatory procedures.
• Prepares submissions to health authorities.

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
• Knowledge of specific local regulations including NOM-059 LGS RIS NOM-072 NOM-073 and NOM-164

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.

Why AstraZeneca

At AstraZeneca were dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. Theres 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. Were on an exciting journey to pioneer the future of healthcare.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.