Global Regulatory Lead/Regulatory Principal Specialist
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Søborg
Join Global Regulatory Affairs as Global Regulatory Lead CagriSema Obesity and become part of a dynamic and exciting organisation where engaged people are committed to obtain Marketing Authorisations for Novo Nordisk’s innovative medicines by regulatory authorities across the globe. We have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. Apply now! The position The department is expanding as the project progresses into multiple indications, late-stage development, and submission. Therefore, we are looking for a candidate with a strong scientific background combined with regulatory drug development experience to take on the role of Global Regulatory Lead and become part of the RA team for one of our high-priority late-stage development projects. Your tasks will include the following: Drive and coordinate several regulatory activities with challenging and often overlapping timelines
Provide strategic input and regulatory expertise to the project development plan and organisation; also evaluate project risks and recommend regulatory mitigations
Interact with internal and external stakeholders and be a member of cross functional project teams
Ensure regulatory deliverables successfully meet project and business objectives while adhering to regulatory requirements and guidance within drug development
Assume the role of the challenger who makes an impact, seeks solutions, and drives innovation
As a Global Regulatory Lead CagriSema Obesity, you will report to the Senior Director of RA CagriSema and take active part in department related activities, including improvement projects across Regulatory Affairs. Although, we prefer that you work from our office in Søborg, Denmark, there is a possibility to work remotely. Qualifications To be successful in this role, you need: Master’s degree in life science or similar
10+ years of Regulatory Affairs experience within late-stage development and/or early life-cycle management
Solid experience with defining and developing global regulatory strategies and good all-around understanding of the regulatory documentation and requirements for pharmaceutical development and licensing
Be experienced in interacting directly with regulatory authorities on an international scale
Fluent written and spoken English
As a person, you are a team player with solid problem-solving capabilities, strategic focus, and organizational skills. You can keep your spirits high even when under pressure. You are a skilled communicator who can collaborate at any organisational level. About the department Regulatory Affairs CagriSema currently consists of 25 dedicated and highly engaged employees. Our department is responsible for the development of global regulatory strategies to advance the project within multiple indications from early stages of development to worldwide submission and approvals of initial Marketing Authorisation applications. We work as an integrated part of the global development organisation and play a key role in the cross-functional teams. We are responsible for the development, implementation and execution of global regulatory strategies and regulatory operational activities in alignment with the global project development plan. We drive label development, health authority interactions and regulatory submissions, hereunder initial marketing authorisation applications, paediatric plans, and clinical trial applications. We have a close collaboration with our affiliates and global stakeholders. 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 embrace the spirit of experimentation, striving for excellence without fixating on perfection. 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 Eva Thomsen at [email protected]. Deadline 6 August 2023. Please note, we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. 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 5.6.2023, 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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