Senior Regulatory Professionals
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Søborg
Are you able to cut through complexity and drive regulatory strategies for high impact projects? Would you like to work together with experts across multiple functions in a global environment? Do you want to be part of an exciting environment where engaged people are committed to bring innovative treatment to patients across the globe? Then come join us at Novo Nordisk as Senior Regulatory Professional in Regulatory Affairs (RA). Our people have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and stakeholders. Apply now! The position As Senior Regulatory Professional, you will take part in developing regulatory strategies and lead execution via interactions with cross-functional teams. We have two vacant positions within NASH (Non-Alcoholic Steatohepatitis) and other chronic liver diseases: one for a project that is entering submission phase and the other position for projects in the stage of phase 2. The projects are pursuing liver indications where there is yet no approved medicinal product, with a high unmet medical need, and in a regulatory environment that is still in its infancy. A combination that makes the position truly exiting and with great room for innovation and drive. You will report to the Senior Director of RA NASH and take active part in department related activities, including improvement projects across RA. You will work closely with project management, medical and non-clinical experts, statisticians, and medical writers. As Senior Regulatory Professional, you will be involved in strategic regulatory activities including: Contributing to global regulatory strategies and tactics by providing your specialist knowledge via analysing regulatory opportunities and risks Ensuring that the project strategy is implemented in clinical trial protocols and documents supporting clinical trial applications Taking the lead in preparing briefing packages for Health Authority interactions worldwide and developing global label claims, including translating them into local label text for submission in target countries You will also be responsible for tactical actions ensuring execution according to the regulatory strategies, this will include: Ensuring timely submission of clinical trial applications to progress the clinical programme Leading major submission tracks as submission country lead, working with affiliates to ensure alignment between local and global regulatory strategies and timely preparation of documentation Driving global roll-out and submission plans This role provides opportunity for personal and professional growth in a dynamic and cooperative environment. We value team spirit, collaboration, knowledge-sharing, and skilled colleagues. Join our empowering culture and work alongside talented, supportive, and humble teammates. Although we prefer that you work from our office in Søborg, Denmark, there is a possibility to work remotely with the right candidate. Qualifications
As an ideal candidate, you need to have: Master’s degree or Ph.D. in science, pharmaceutical or health science Solid and hands-on regulatory experience in the pharmaceutical industry and with a good understanding of the R&D (Research & Development) value chain Proven global regulatory strategy experience, including employment of expedited pathways across major regulatory agencies, and handling pharmaceutical development documentation (quality, non-clinical, clinical). Good pharmaceutical industry knowledge and proficiency in interacting with regulatory authorities on an international scale Ability to communicate in fluent English (both written and spoken) Demonstrating proactivity and employing excellent project management skills are essential to this role. You should be able to set clear direction and take the initiative to ensure tasks are completed efficiently. Additionally, you should be a team player who is willing to assist colleagues and work towards shared objectives. This means having an inclusive mindset and respecting the diversity of others. In addition to being flexible and change-oriented, you should enjoy experimenting and seeing opportunities in challenging situations. Finally, a good sense of humor and the ability to remain positive and motivated under pressure is considered an advantage. About the department
You will join the expanding department of RA NASH situated in Søborg, Denmark. We work on development projects ranging from early research entailing candidate selection through to late-stage development and filing of Marketing Authorization applications globally. We have a broad and expanding portfolio within the serious chronic liver disease NASH as well as other liver indications; indications that severely affect millions of people globally and with no current treatment options. We are currently 11 dedicated and highly engaged employees in the department with diverse backgrounds and experience. We work in a flexible set-up where trust and openness, sparring, challenge, and knowledge sharing foster an inclusive and innovative culture we all enjoy being part of. The atmosphere is informal and good humour is always welcome. 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 Tara Elvang +45 30752456. Deadline 30 April 2023. Relevant candidates may be invited for an interview before deadline. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation to applying for this position in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. Should you wish to learn more about Regulatory Affairs careers, here may be a good place for you to begin: https://www.novonordisk.com/careers/career-areas/research-and-development/regulatory-affairs-careers.html 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.
As an ideal candidate, you need to have:
You will join the expanding department of RA NASH situated in Søborg, Denmark. We work on development projects ranging from early research entailing candidate selection through to late-stage development and filing of Marketing Authorization applications globally. We have a broad and expanding portfolio within the serious chronic liver disease NASH as well as other liver indications; indications that severely affect millions of people globally and with no current treatment options. We are currently 11 dedicated and highly engaged employees in the department with diverse backgrounds and experience. We work in a flexible set-up where trust and openness, sparring, challenge, and knowledge sharing foster an inclusive and innovative culture we all enjoy being part of. The atmosphere is informal and good humour is always welcome. 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 Tara Elvang +45 30752456. Deadline 30 April 2023. Relevant candidates may be invited for an interview before deadline. You do not need to attach a cover letter to your application, but please include a few sentences about your motivation to applying for this position in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV. Should you wish to learn more about Regulatory Affairs careers, here may be a good place for you to begin: https://www.novonordisk.com/careers/career-areas/research-and-development/regulatory-affairs-careers.html 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 5.4.2023, 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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