Regulatory Professional
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Søborg
Are you eager to make a real difference in the lives of patients around the world? At Novo Nordisk Regulatory Affairs CMC (Chemical, Manufacturing, and Controls), we lead the charge in revolutionizing healthcare through cutting-edge research and development. As a critical link between ground-breaking science and global commercial access, we take pride in being the driving force behind life-changing treatments. We consider ourselves the essential glue that connects visionary research to tangible patient outcomes, spanning the entire research and development value chain from the earliest stages of drug development to securing vital commercial licenses, and remaining committed to staying one step ahead for both our patients and our business. If this sounds attractive to you, then do not hesitate to apply now for ourRegulatory Professional position in RA CMC Diabetes & Obesity! The position We are looking for a new colleague with a strong scientific and technical mindset to work with our diabetes and obesity portfolio in Regulatory Affairs CMC. We cover projects from the very earliest stages of the development towards the first marketing authorisation, as well as continuing the product roll out globally and optimising the product throughout life cycle management. Your responsibilities will include the following: Provide input to all regulatory submissions to Health Authorities worldwide for the projects you work with to obtain the regulatory approvals Turn your scientific knowledge into regulatory pathways and develop global regulatory CMC strategies together with the team based on current legislation and regulations Work closely with colleagues across the organisation and represent RA CMC in relevant cross functional RA matrixes and stakeholder groups ensuring alignment of planning and strategy across areas This role offers an opportunity for you to continue your individual development and connect your scientific background to the regulatory framework of CMC in benefit of the patients. You will work in a fast-paced environment with tight deadlines and collaborate closely together with regulatory colleagues across our +80 offices around the world. The atmosphere is informal and good humour is always welcome. Our commitment to innovation also applies to the way we work: We embrace a flexible workplace, with a blend of in-office and remote work. Qualifications As an ideal candidate, you: Hold a Master’s degree or Ph.D. in Science, Pharmacy, Engineering, or another relevant academic field Have +2 years of relevant experience, e.g., working with Regulatory Affairs, product development, or other relevant area of the pharmaceutical industry Excellent planning and coordination skills to handle complex tasks for yourself and others are considered an advantage On a personal level, you are proactive, self-motivated, solution oriented and curious to learn. You are comfortable speaking your mind, enjoy a challenging problem and own a strong personal drive. You have a strategic mindset and the ability to set direction for your projects. Furthermore, you bring positive attitude, are flexible and have a professional and personal impact that is reflected in your desire to take initiative. About the department RA CMC Diabetes & Obesity is part of the RA CMC & Device area in Development in Novo Nordisk. Our department is made of 50 colleagues working in different project teams from early phases of drug development throughout the life cycle of the marketed products worldwide. We are responsible for driving the RA CMC strategy and submission activities related to both the drug-device projects and the oral projects. Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. This requires a strong sense of teamwork, collaborative thinking, skilled colleagues, and a focus on knowledge-sharing. As a member of our team, you can look forward to being surrounded by talented, collaborative, and embracing teammates in a strong and empowering culture filled with humble people. 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, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact
For further information please contact Samantha Donslund Schwab (+45 30794018) or Jeppe Engelheim Müggler (+45 30756025). Deadline
16 August 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. 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.
For further information please contact Samantha Donslund Schwab (+45 30794018) or Jeppe Engelheim Müggler (+45 30756025). Deadline
16 August 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline. 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 25.7.2023, 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.
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