Regulatory Affairs Analyst

hace 6 meses

Santiago de Chile Novo Nordisk A tiempo completo

Can you drive the global strategy for culture, engagement and performance management at Novo Nordisk? Do you have the interpersonal skills to navigate in a complex stakeholder landscape and are you able to motivate, set direction and deliver results? At Novo Nordisk, we are our people. And together we can make an impact.

**The Position**

**Main responsibilities**
- Ensure regulatory compliance on import activities; Compilation, preparation, and submission of import permits according to local legislation for medicinal products, samples, and medical devices; Follow-up and immediate notification to all involved areas when approval is obtained;
- Compiling, submission and approval of NDA and LCM; Assess registration files ensuring compliance of file content with regulatory requirements; Handle and follow up of HAs queries, requests, and demands; Ensure timely submission and follow-up of variations to the local HA, in cooperation with the key stakeholders; Management of the renewals and LCM activities; Ensure internal systems and databases are updated
- Development of packaging materials; Ensure development, review, and update of labelling materials according to local legislation and SOPs; Ensure correct and timely submission of PPM updates and labelling proofreading according to HQ deadlines
- Monitor the regulatory environment; Monitor regulatory environment and inform Quality Assurance and Regulatory Affairs department and, if applicable, impacted areas within the organisation about changes in local regulations

**Qualifications**
- University degree in Pharmacy (degree validated in Chile)
- Fluent in oral and written English & Spanish
- At least 1 years’ experience in the Regulatory affairs area for pharmaceutical industry
- Knowledge of local legislation. Regional legislation awareness desirable
- Highly desirable kwnoledge on regulatory process of biological products

**About the Department**

At Novo Nordisk Chile our purpose is to promote changes to defeat diabetes and other serious chronic diseases such as obesity, rare blood and endocrine diseases. We do this by pioneering scientific advancement, expanding access to our medicines, and working to prevent and ultimately cure the diseases we treat.
More than 110 people are part of this affiliate, and we recognize the need to adopt experimentation and strive for diversity and inclusion to make better decisions, ensuring that multiple perspectives are considered.
Together we are changing lives.

**Working at Novo Nordisk**

At Novo Nordisk, we don’t wait for change. We drive change. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further.

**Contact**:
**Deadline**

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

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 for 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 communities we operate in.

Together, we’re life changing.

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