Regulatory Affairs Coordinator

Are you an expert in regulatory affairs within the pharmaceutical industry?
Do you have experience in ensuring regulatory compliance for new products and product amendments?
We are looking for a Regulatory Affairs Coordinator to join our team in Mexico City.
If you are ready for a new challenge and want to make a difference in the healthcare industry, read on and apply today for a life-changing career.
The Position As a Regulatory Affairs Coordinator at Novo Nordisk, you will be responsible for: Developing regulatory strategies and submitting applications for new drug approvals, product variations, renewals, import licenses, and promotional materials.
Coordinating the preparation, submission, and response to health authorities for regulatory files.
Planning and conducting regulatory interactions with health authorities, including technical meetings and taking minutes of formal meetings.
Coordinating regulatory intelligence processes to ensure timely updates on regulatory changes and market information.
Coordinating promotional practices for assigned products.
Qualifications To be successful in this role, you should have: A bachelor's degree in a relevant field, such as Pharmaceutical Chemist Biologist (QFB) or a career linked to regulatory affairs in the pharmaceutical industry.
5-8 years of relevant experience in a similar transnational pharmaceutical company and role & general experience with biotech products, medical devices, and orphan products.
Fluent written and spoken English.
Good understanding of local regulatory requirements, including ICH requirements and WHO guidelines for biotech products.
Regulatory intelligence skills.
About the Department The Regulatory Affairs department at Novo Nordisk is responsible for ensuring regulatory compliance for new products and product amendments.
We work closely with health authorities and policymakers to shape future regulatory frameworks.
In addition, we safeguard patient safety by collecting, analyzing, and reporting safety data for both clinical trials and marketed products.
As a Regulatory Affairs Coordinator, you will be part of a team that plays a crucial role in ensuring our organization's license to operate.