Regulatory Specialist

Job Description

Do you have a strong desire to be part of a patient-centric company improving patient lives? Novo Nordisk Iran has opened a role for a Regulatory Specialist. Apply now and be part of life-changing careers at Novo Nordisk. About Novo Nordisk: Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, hemophilia, growth disorders, and other serious chronic diseases. The position: As a regulatory specialist, you will be responsible for coordinating regulatory affairs applications related to Product Life Cycle Management (LCM) and/or New Drug Approvals (NDA) in Iran. Managing the compiling, submission, and approval activities for New Drug Application (NDA) and Life Cycle Management (LCM) licenses under the supervision of the RA Manager. ● Assist RA in monitoring the regulatory environment and ensuring compliance. ● Provide information on local regulatory requirements to other departments. ● Draft routine correspondence to FDO concerning import, release, and distribution permissions. ● Manage compile, coordinate, and supervise regulatory affairs applications related to NDA and LCM. ● Assess registration files, ensuring adequate follow-up with regulations. ● Review the list of documents required for submission and provide on-time product information as needed. ● Provide regulatory support and insight to critical stakeholders and RA managers. ● Establish and maintain fluent and open interaction and cooperation with other departments (Quality, marketing, legal, logistics, medical, and HAs). Contact: Please send/upload your CV only in English. Due to the high volume of applications being received for this role, please note that only qualified candidates will be contacted. Working at Novo Nordisk: At Novo Nordisk, we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company in the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve, and the communities we operate in. Together, we’re life-changing. Millions rely on us: To work for Novo Nordisk, you will need the skills, dedication, and ambition to change lives for the better for millions of patients living with diabetes and other chronic diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.