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Regulatory Affairs Manager - Malmö, Sverige - Novo Nordisk A/S
Beskrivning
Are you highly motivated by being able to make a difference to improving patients' lives? Are you a high- performing person, who gets energized by challenges and is able to motivate people around you?
The position as Regulatory Affairs Manager will give you the opportunity to work in a high performing team and contribute directly towards the business results, while creating values for patients.
If it sounds interesting, continue reading and apply today for a life-changing career
The Position
You will ensure products can be placed on the market with optimal yet compliant claims, advertising, and promotion in line with the commercial plans. You will also ensure products are maintained and meet internal and external compliance requirements. You will be a productive part of a defined local regulatory team, which includes being a proactive partner to other stakeholders. As part of the role, you will engage with the external regulatory environment within a defined area of accountability, and act as the voice of Novo Nordisk. The Regulatory Affairs Manager works together with our colleagues from the regulatory departments in the EU countries, as well as other stakeholders to proactively look for opportunities and solutions to challenges.
Your main responsibilities will be:
• To be the overall responsible for regulatory activities of a defined product portfolio at Novo Nordisk Sweden
• To take charge of Life Cycle Management of marketed products in Sweden, from updating product information, packaging material, and introducing new products to the Swedish market
• To lead the development of strategies and plans to mitigate, so that we can launch in a timely manner robust products that are aligned with business needs and backed by science
• To monitor the external regulatory landscape in Sweden, including local legislation as well as contact and liaise with authorities such as the Swedish Medical Products Agency.
Moreover, you will actively contribute to high performing teams, including looking for ways to improve performance, build relationships with key stakeholders and represent Novo Nordisk in a responsible manner, according to our company values. It will be crucial to be able to communicate our policies and strategies, and negotiate outcomes, as well as manage compliance within defined portfolio/activity streams in line with Novo Nordisk.
Qualifications
The candidate who will thrive in this role:
• Has a background in healthcare or in the life sciences and preferably a few years of work experience with regulatory submissions/approvals
• Is a structured and a proactive planner with an eye for detail and great time management skills, who is able to handle several tasks at the same time
• Is tech- savvy and able to handle complex IT systems as part of the daily work
• Is a fluent speaker of both Swedish and English that can communicate in a persuasive and impactful way.
About the Department
You will join a small team that is composed of passionate people who strive for excellence and take pride in being the license to operate. In our team we are ongoingly looking at our processes and how we can work smarter while meeting the obligations and legal requirements. The position sits within the Regulatory, Safety and Quality team in Malmö, Sweden and you will report directly to the Head of Regulatory, Safety, and Quality. The Department is responsible for managing all regulatory, safety, and quality operations in full compliance with corporate and legal requirements. With this position, the Department consists of 6 colleagues and the Head of Regulatory, Safety, and Quality.
