Regulatory, Safety & Quality Manager

Do you want to lead a team in Regulatory Affairs, Safety & Quality? Do you want to embrace a key position in maximising patient safety and access to innovative treatments? Do you see yourself as passionate about process improvement? If you answered yes, you may be the person we are looking for!

About the department: Novo Nordisk is a global healthcare company with almost 100 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people living with obesity, haemophilia and growth disorders.

The Clinical, Medical and Regulatory Department at Novo Nordisk Portugal has more than 20 people who give their best everyday to speed up patient access to innovation. We now offer this exciting opportunity for personal and professional development among great colleagues, in a knowledge-sharing environment.

The position

As Regulatory, Safety & Quality Manager you will report to the Medical Director and will be responsible for:

• Leading Novo Nordisk Portugal Regulatory, Safety and Quality processes in support of business goals and in compliance with relevant laws and regulations;


• Leading a team of 2 Regulatory and Safety professionals, coaching, motivating and developing your direct reports;


• Acting as Novo Nordisk Technical Director, for medicines and medical devices;


• Collaboration with INFARMED;


• Responsible for submitting marketing authorizations, variations and renewals of medicinal products;


• Responsible for handling Safety tasks in Pharmacovigilance: reporting of AE and CC to HQ and submission of SUSAR reports and DSURs to HA and Ethics Committee;


• Implementation of Novo Nordisk Quality System (QMS) in the Affiliate, ensuring product quality, focusing on business-critical issues that may have an impact on license to operate and inspection readiness;


• Local Quality Representative for Quality Issues

Qualifications and skills

• University Degree in Pharmaceutical Sciences,
  
• Valid registration in the Portuguese Pharmaceutical Society ?Ordem dos Farmacêuticos?,


• Native Portuguese speaker, with permanent Residence in Portugal, in the Lisbon Metropolitan Area,


• In-depth knowledge of regulatory and pharmacovigilance legislation (Portugal and EU), including prescription medicines and medical devices,


• A minimum 5 years of experience in Regulatory, Pharmacovigilance, Quality and/or Technical Direction, from working within the Pharmaceutical industry or wholesaler sector,


• Previous experience as people manager ( 2 years) within the Pharmaceutical industry or wholesaler sector is highly desirable,


• Experience managing multiple simultaneous projects in a fast-paced environment with moving variables,


• Strong leadership skills, winning mindset, agility and ability to set high standards,


• Strong communication and cross-functional collaboration skills,


• Agile in adjusting to environment dynamics,


• Attention to detail and ability to analyse complex technical information,


• Fluent in English.

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 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 the communities we operate in.

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

We are leaders by making a difference for people who face chronic diseases and work with high standards to bring the ultimate innovation to those seeking improved quality of care and life. Each day we are one step closer into changing chronic diseases in Portugal. And we do so by relying and supporting our people, their career development and continuously bring their best to contribute to a joint mission.

For further information, please contact Jorge Caria, [email protected]

Deadline 31 January 2022

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.