Regulatory Writer
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Do you want to influence on our ways of working with new products as well as an expanding portfolio of existing products? Are you passionate about being responsible for writing regulatory submission documents related to finished product manufacturing of BioPharma’s portfolio of haemophilia products and other products for chronic diseases?
If yes, then apply now to our Regulatory Writer role!
The position
As a Regulatory Writer, your responsibility will be, to define the regulatory storyline and create documentation for our portfolio to ensure that the required product's quality is fulfilled and thereby, securing patients safety. You will review and implement new documentation defining specifications, shelf-life stability studies, risk assessments, as well as regulatory submission documents to health authorities.
Your main tasks will also include:
• Cooperate with QC and QA departments, production and regulatory affairs in Denmark and India.
• Use regulatory expertise to provide feedback and keep in touch with health authorities.
• Implementing full-time writers is a newly implemented way of working.
• Strongly involved in defining this cross collaboration going forward. We offer an exciting and stimulating job that requires great energy, initiative, collaboration skills and flexibility.
Qualifications
You will be a great asset to our team because you have: • Master’s degree in Science within Pharmacy, Chemistry, Engineering or a similar field. We also welcome newly graduated applicants.
• Experience either from the pharmaceutical industry or the regulatory area.
• Experience with the health authorities with either writing or reviewing regulatory documents would be an advantage.
• Good communication skills in English, both spoken and written.
As a professional, you are fond of writing and you are good at creating an overview and prioritizing your tasks; even when deadline approaches. Also, you do well in busy environments, challenges do not scare you, and a quality mindset is at your core. Additionally, time management is well appreciated, as well as being an engaged team-player. About the department
Manufacturing Development is a part of Biotech & Rare Disease (BRD) with a team of over 650 colleagues working together to optimize and develop processes across six global production sites. Our field of work broadly covers the area also known as MSAT (Manufacturing, Science, and Technology). We bring value to our patients by driving innovation for the entire BRD, working with Industry 4.0, new technologies, biotechnology, and developing processes for both existing and future products. Working at BRD, Novo Nordisk
BRD is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD, we are not only supplying all Novo Nordisk products to people living with serious chronic diseases, but we also use our competences in biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk.
We are more than 3000 dedicated colleagues working at six production sites in Denmark and the United States. Here we cover the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. As more and more people need our products, we support Novo Nordisk's initiatives in new therapy areas. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology. Contact
For further information, please contact Rasmus Ploug Winchler Larsen, Senior Manager at [email protected] Deadline
24 September 2023 Please note that interviews will be held throughout the period, and we encourage you to apply as soon as possible. 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. 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.
If yes, then apply now to our Regulatory Writer role!
The position
As a Regulatory Writer, your responsibility will be, to define the regulatory storyline and create documentation for our portfolio to ensure that the required product's quality is fulfilled and thereby, securing patients safety. You will review and implement new documentation defining specifications, shelf-life stability studies, risk assessments, as well as regulatory submission documents to health authorities.
Your main tasks will also include:
• Cooperate with QC and QA departments, production and regulatory affairs in Denmark and India.
• Use regulatory expertise to provide feedback and keep in touch with health authorities.
• Implementing full-time writers is a newly implemented way of working.
• Strongly involved in defining this cross collaboration going forward. We offer an exciting and stimulating job that requires great energy, initiative, collaboration skills and flexibility.
Qualifications
You will be a great asset to our team because you have: • Master’s degree in Science within Pharmacy, Chemistry, Engineering or a similar field. We also welcome newly graduated applicants.
• Experience either from the pharmaceutical industry or the regulatory area.
• Experience with the health authorities with either writing or reviewing regulatory documents would be an advantage.
• Good communication skills in English, both spoken and written.
As a professional, you are fond of writing and you are good at creating an overview and prioritizing your tasks; even when deadline approaches. Also, you do well in busy environments, challenges do not scare you, and a quality mindset is at your core. Additionally, time management is well appreciated, as well as being an engaged team-player. About the department
Manufacturing Development is a part of Biotech & Rare Disease (BRD) with a team of over 650 colleagues working together to optimize and develop processes across six global production sites. Our field of work broadly covers the area also known as MSAT (Manufacturing, Science, and Technology). We bring value to our patients by driving innovation for the entire BRD, working with Industry 4.0, new technologies, biotechnology, and developing processes for both existing and future products. Working at BRD, Novo Nordisk
BRD is part of Novo Nordisk Product Supply, which is a global production network at the forefront of technology and quality production of pharmaceutical products. In BRD, we are not only supplying all Novo Nordisk products to people living with serious chronic diseases, but we also use our competences in biotech to support the growing efforts into completely new production platforms and therapy areas for Novo Nordisk.
We are more than 3000 dedicated colleagues working at six production sites in Denmark and the United States. Here we cover the entire production value chain where raw materials are cultivated, purified, formulated, filled, assembled in devices, packed, and distributed across the globe. As more and more people need our products, we support Novo Nordisk's initiatives in new therapy areas. Every day, we work to streamline and expand our capacity through process innovation, automation, and the introduction of new technology. Contact
For further information, please contact Rasmus Ploug Winchler Larsen, Senior Manager at [email protected] Deadline
24 September 2023 Please note that interviews will be held throughout the period, and we encourage you to apply as soon as possible. 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. 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 Gentofte.
Jobbet er oprettet på vores service den 7.9.2023, 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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