Regulatory Affairs Coordinator

Regulatory Affairs Coordinator**Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Ciudad de México, Ciudad de México, MX- Regulatory Affairs Department- Mexico City, Mexico**Your new role**- As a Regulatory Affairs Coordinator, you will:- Ensure that Novo Nordisk's portfolio has all necessary COFEPRIS authorisations to be sold in Mexico.- Conduct scientific assessments to support regulatory submissions.- Develop product registration dossiers, progress reports, supplements, amendments, and periodic experience reports.- Ensure compliance with local regulatory requirements, including COFEPRIS guidelines and ICH standards for biotech products.- Provide strategic direction to teams on regulatory interactions and negotiate evidence with regulatory agencies.- Maintain a controlled documentation system, ensuring compliance with regulatory requirements and electronic records retention processes.- Serve as a regulatory liaison throughout the product lifecycle, including risk management, labelling, and submission processes.- Collaborate with marketing, research, and production teams to ensure regulatory compliance and timely approvals.- Monitor and analyse safety data, ensuring medicines are safe for use and addressing any potential safety issues.**Your new department**- You will be part of the Regulatory Affairs team in Mexico, a dynamic and fast-paced environment dedicated to ensuring regulatory compliance and patient safety.Our team is responsible for gaining regulatory approvals for clinical trials, new drugs, and devices, as well as maintaining the availability of existing products.We work closely with health authorities and policymakers to shape future regulatory frameworks.- In addition to regulatory affairs, our team also focuses on safety pharmacovigilance, ensuring that our medicines are safe for use and addressing any safety concerns that arise.Joining our team means being part of a collaborative and impactful group that plays a critical role in Novo Nordisk's mission to improve patient outcomes.**Your skills and qualifications**- Need to have:- 5 to 8 years of relevant experience in a similar role at a transnational pharmaceutical company.- Solid understanding of local regulatory requirements, COFEPRIS guidelines, and CTD presentations (including ICH requirements for biotech products).- Advanced English proficiency (written and spoken).- Strong stakeholder management skills and a results-oriented mindset.- Business vision and the ability to develop and execute strategic plans.- Hands-on approach with the ability to make things happen.- Desired skills:- Experience with biotech products, New Molecules Committee, and orphan products.- Impact and influence skills with a customer-oriented focus.**Working at Novo Nordisk**- Every day we seek the solutions that defeat serious chronic diseases.To do this, we approach our work with an unconventional spirit, a rare determination and a constant curiosity.For over 100 years this unordinary mindset has seen us build a company unlike any other.One where a collective passion for our purpose, mutual respect and a willingness to go beyond what we know delivers extraordinary results.**What we offer**- There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce.Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind.**More information****Deadline**- We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.- We're not your typical healthcare company.In a modern world of quick fixes, we focus on solutions to defeat serious chronic diseases and promote long-term health.Our unordinary mindset is at the heart of everything we do.We seek out new ideas and put people first as we push the boundaries of science, make healthcare more accessible, and treat, prevent, and even cure diseases that affect millions of lives.Because it takes an unordinary approach to drive real, lasting change in health.