Submission Specialist
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Bagsværd
Do you want to have an impact on how we write regulatory submission documents for approval of new finished products? Do you thrive in an environment where you can ensure a smooth process and interaction with health authorities throughout a submission and Q&A process?
Then apply now and join a team that will set the standards of regulatory submission documents for Novo Nordisk growing pipeline of new injectable drug products.
The position
We are now hiring a Submission Specialist who will be involved in developing the vision and setting the direction for how we work with regulatory documents going forward.
Your main responsibilities will include: Define and keep the overview of the regulatory storyline. Create documentation for our portfolio to ensure that the required product's quality is fulfilled and thereby, securing patients’ safety. Review and implement new documentation defining specifications, shelf-life stability studies, risk assessments, as well as regulatory submission documents to health authorities. Use your regulatory expertise to provide feedback, secure answers to questions from various health authorities, and keep in touch with them. Structure and coordination of a complex documentation and submissions portfolio. Identify and implement new tools and ways of working to simplify and streamline submissions for new and existing products. You will do this in cooperation with your colleagues across two departments in Injectable Finished Products (IFP) Manufacturing Development, in the development departments (CMC), QC, QA, production, and in regulatory affairs. In exchange, we offer an exciting and stimulating job that requires great energy, initiative, collaboration skills, and flexibility.
Qualifications
The qualifications we are looking for are: An academic degree in Science within Pharmacy, Chemistry, Engineering, or a similar field. Experience either from the pharmaceutical industry, the regulatory area or from the health authorities in either writing or reviewing regulatory documents. Excellent ability to plan and coordinate the writing work in line with an ambitious submission strategy. Ability to set the direction for building a regulatory submissions competence and collaboration hub in Novo Nordisk Product Supply. You are good at creating an overview and prioritizing your tasks while meeting the deadlines. Great communication skills in English, both spoken and written. As a person, you do well in busy environments, challenges do not scare you, and a quality mindset is at your core. Time management is well appreciated, as well as being an engaged team player.
About the department
In IFP Manufacturing Development we are responsible for the specifications of finished products and transfer of products from Chemistry, Manufacturing and Control (CMC) to our production facilities in Product Supply (PS) and the support of our aseptic productions. Further, we seek innovative solutions to and optimizations of all our processes and write the associated documents to authorities worldwide plus answering Q&A’s.
The submission specialist will have their base in IFP ManDev – New Product Introduction, which is responsible for scale up and launch, but will work very closely with colleagues in Site Support and Improvement. The role will to a high extent tie the work of the two departments together and ensure to create a clear regulatory thread throughout the submission.
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 call Maria Berggård Silow Senior, Manager at +45-34485056.
Deadline
29 October 2023.
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.
Then apply now and join a team that will set the standards of regulatory submission documents for Novo Nordisk growing pipeline of new injectable drug products.
The position
We are now hiring a Submission Specialist who will be involved in developing the vision and setting the direction for how we work with regulatory documents going forward.
Your main responsibilities will include:
Qualifications
The qualifications we are looking for are:
About the department
In IFP Manufacturing Development we are responsible for the specifications of finished products and transfer of products from Chemistry, Manufacturing and Control (CMC) to our production facilities in Product Supply (PS) and the support of our aseptic productions. Further, we seek innovative solutions to and optimizations of all our processes and write the associated documents to authorities worldwide plus answering Q&A’s.
The submission specialist will have their base in IFP ManDev – New Product Introduction, which is responsible for scale up and launch, but will work very closely with colleagues in Site Support and Improvement. The role will to a high extent tie the work of the two departments together and ensure to create a clear regulatory thread throughout the submission.
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 call Maria Berggård Silow Senior, Manager at +45-34485056.
Deadline
29 October 2023.
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 Bagsværd.
Jobbet er oprettet på vores service den 19.10.2023, 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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