Senior RA Policy Specialist
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Søborg
Are you ready to embark on an extraordinary journey in a fast-changing environment, where innovation and expertise merge to drive the global success of Novo Nordisk's life-changing products? Do you want to join company that can help you develop your skills across various domains and enhance your professional growth through valuable experiences? At Novo Nordisk Global Regulatory Affairs, we are committed to ensuring approval of our groundbreaking health solutions and maintaining our license to operate across the globe. We are currently searching for a highly skilled and motivated Senior RA Policy Specialist to join our dynamic team. Apply now!
The position
In this role, you will be expected to make an impact by striving for improvement of the external regulatory frameworks that regulate our business. The job is a unique opportunity to demonstrate your capacity for devising and carrying out strategies for analysing, responding to, and influencing new regulatory requirements. Main responsibilities include: Conducting impact assessments on new and draft requirements, guidelines, and standards that affect Novo Nordisk's regulatory procedures Driving the development of Novo Nordisk's responses to these requirements, ensuring compliance and regulatory excellence Identifying the need for policy advocacy activities and strategically planning and executing initiatives to influence regulatory policies Navigating internal priorities within Novo Nordisk, leveraging the collective knowledge of the Regulatory Affairs team and the wider organization through frequent collaboration Representing Novo Nordisk in relevant external fora, including seminars, conferences, and as member of industry association working groups You will report to the Vice-President of Global RA Policy & Intelligence, and you will preferably be based in Søborg, Denmark.
Qualifications
As a highly suitable candidate, you possess the following: Academic degree in Pharmacy or similar Significant professional expertise and a proven track record working in Pharmaceutical, Device or MedTech Regulatory Affairs e.g., as part of a product development team Experience working with industry associations or consortia Experience with device and/or combination product regulatory requirements, guidelines and standards and practices, primarily in the European Union other markets will be a plus Fluency in written and spoken English
On a personal level, you have a strategic mindset and possess great stakeholder management skills. You exhibit independence, a results-driven approach, and thrive when faced with challenges. Your ability to effectively communicate complex issues in a clear and concise manner is crucial, as excellent communication and presentation skills are also required. About the department
You will be part of Global Regulatory Affairs Policy & Intelligence. The department works to ensure compliance with new and updated external regulatory requirements, guidelines, and standards, while also exerting influence on the external regulatory frameworks, and advising Novo Nordisk product teams on regulatory strategic opportunities and challenges. Through our collective efforts, we actively support Novo Nordisk’s product development and life cycle management strategies on all fronts and promote overall regulatory excellence within the company. We work in a hybrid setting and across time zones, and the department is based physically in Søborg Denmark, Istanbul Turkey, and Bangalore India.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. 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 never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Ane Sofie Böhm Nielsen: +45 30 75 53 26.
Deadline
31 July 2023. Please refrain from adding a photo in your CV. Novo Nordisk commits to an inclusive recruitment process and equality of opportunity for all job applicants. 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.
The position
In this role, you will be expected to make an impact by striving for improvement of the external regulatory frameworks that regulate our business. The job is a unique opportunity to demonstrate your capacity for devising and carrying out strategies for analysing, responding to, and influencing new regulatory requirements. Main responsibilities include:
Qualifications
As a highly suitable candidate, you possess the following:
On a personal level, you have a strategic mindset and possess great stakeholder management skills. You exhibit independence, a results-driven approach, and thrive when faced with challenges. Your ability to effectively communicate complex issues in a clear and concise manner is crucial, as excellent communication and presentation skills are also required. About the department
You will be part of Global Regulatory Affairs Policy & Intelligence. The department works to ensure compliance with new and updated external regulatory requirements, guidelines, and standards, while also exerting influence on the external regulatory frameworks, and advising Novo Nordisk product teams on regulatory strategic opportunities and challenges. Through our collective efforts, we actively support Novo Nordisk’s product development and life cycle management strategies on all fronts and promote overall regulatory excellence within the company. We work in a hybrid setting and across time zones, and the department is based physically in Søborg Denmark, Istanbul Turkey, and Bangalore India.
Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive it. 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 never shy away from opportunities to develop, we seize them. From research and development to manufacturing, marketing, and sales – we’re all working to move the needle on patient care.
Contact
For further information, please contact Ane Sofie Böhm Nielsen: +45 30 75 53 26.
Deadline
31 July 2023. Please refrain from adding a photo in your CV. Novo Nordisk commits to an inclusive recruitment process and equality of opportunity for all job applicants. 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.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 30.6.2023, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Søborg
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