Facility Expert - Regulatory Affairs CMC
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Søborg
Do you want to be part of a dynamic and exciting organisation and have the opportunity of transforming the way Regulatory Affairs operates? If yes, we are seeking a highly motivated and skilled Facility Expert to join our Regulatory Affairs (RA) team and drive facility expansion projects within RA CMC & Device, Biotech and Rare disease portfolio. If you are an ambitious, GMP-minded individual with a passion for driving cross-product projects, we encourage you to apply for this exciting opportunity. We offer a competitive salary and benefits package, as well as opportunities for growth and development within our organization. Apply now! The position
In this role, you will be at the forefront of driving facility approvals within RA CMC & Device, demonstrating a proactive approach to enhance manufacturing flexibility. Your responsibilities will extend to overseeing the implementation of the regulatory strategies, ensuring excellent stakeholder relations. Your main responsibilities will be focused on:
• Keeping the facility plans updated in Vault RIM, aligning it with evolving organizational needs
• Continuous monitoring and RA assessment of Product Supply Biotech and Rare Disease facility plans, identifying RA impact and strategies together with PS project managers
• Being a key figure in assessing change requests to allow for facility changes
• Collaborating with cross-functional teams, allowing for the effective implementation and integration of strategies across the organization in compliance with regulatory requirements and guidelines
In addition, you will be part of developing the future regulatory facility documentation applicable within all Novo Nordisk. Qualifications
To be a competitive candidate, you should have:
• A MSc degree related to Life Science or other educational background with extensive experience related to the role
• Strong GMP thinking with a proven track record of driving regulatory strategies for new/revamped facilities
• Hands on regulatory facility experience
• Project Management experience
• Motivation by facilities and equipment challenges and always looking for new and innovative ways to optimize the regulatory processes
• Flair for IT systems; experience with Vault RIM is an advantage as our processes are anchored in this system
On a personal level, you have excellent communication and collaboration skills which are fundamental in this role for effective interaction with others. You are self-motivated which signifies an internal drive and initiative to accomplish tasks independently. This quality is complemented by the versatility to seamlessly transition between working independently and collaboratively within a team setting. Finally, you have a strong attention to detail and the ability to work in a fast-paced environment. Fluency in English, encompassing both verbal and written communication, is an essential skill for effective engagement and collaboration with various stakeholders.
About the department
You will be anchored in RA Facility & Projects, part of the Submission Excellence area, as a functional unit in RA CMC & Device. We have the overall purpose of driving a continuously ambitious LCM agenda to ensure flexibility in the supply network and to act as strategic partner to manufacturing and capacity expansion projects. RA Facility & Projects is involved in the full lifecycle of initial submissions to late LCM, with the responsibility of facility relevant documentation in the dossier, as well as the early involvement and strategy creation for manufacturing expansion projects, incl. coordination and roll out to global markets.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we’re life changing. Contact
For further information, please contact Director Malene Østergaard Jørgensen, at +45 30795844 Deadline
4 February 2024. 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.
In this role, you will be at the forefront of driving facility approvals within RA CMC & Device, demonstrating a proactive approach to enhance manufacturing flexibility. Your responsibilities will extend to overseeing the implementation of the regulatory strategies, ensuring excellent stakeholder relations. Your main responsibilities will be focused on:
• Keeping the facility plans updated in Vault RIM, aligning it with evolving organizational needs
• Continuous monitoring and RA assessment of Product Supply Biotech and Rare Disease facility plans, identifying RA impact and strategies together with PS project managers
• Being a key figure in assessing change requests to allow for facility changes
• Collaborating with cross-functional teams, allowing for the effective implementation and integration of strategies across the organization in compliance with regulatory requirements and guidelines
In addition, you will be part of developing the future regulatory facility documentation applicable within all Novo Nordisk. Qualifications
To be a competitive candidate, you should have:
• A MSc degree related to Life Science or other educational background with extensive experience related to the role
• Strong GMP thinking with a proven track record of driving regulatory strategies for new/revamped facilities
• Hands on regulatory facility experience
• Project Management experience
• Motivation by facilities and equipment challenges and always looking for new and innovative ways to optimize the regulatory processes
• Flair for IT systems; experience with Vault RIM is an advantage as our processes are anchored in this system
On a personal level, you have excellent communication and collaboration skills which are fundamental in this role for effective interaction with others. You are self-motivated which signifies an internal drive and initiative to accomplish tasks independently. This quality is complemented by the versatility to seamlessly transition between working independently and collaboratively within a team setting. Finally, you have a strong attention to detail and the ability to work in a fast-paced environment. Fluency in English, encompassing both verbal and written communication, is an essential skill for effective engagement and collaboration with various stakeholders.
About the department
You will be anchored in RA Facility & Projects, part of the Submission Excellence area, as a functional unit in RA CMC & Device. We have the overall purpose of driving a continuously ambitious LCM agenda to ensure flexibility in the supply network and to act as strategic partner to manufacturing and capacity expansion projects. RA Facility & Projects is involved in the full lifecycle of initial submissions to late LCM, with the responsibility of facility relevant documentation in the dossier, as well as the early involvement and strategy creation for manufacturing expansion projects, incl. coordination and roll out to global markets.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 50,000 employees. Together, we go further. Together, we’re life changing. Contact
For further information, please contact Director Malene Østergaard Jørgensen, at +45 30795844 Deadline
4 February 2024. 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 "Apoteker", og befinder sig i kategorien "Sundhed og forskning".
Arbejdsstedet er beliggende i Søborg.
Jobbet er oprettet på vores service den 23.1.2024, 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.
- Apoteker
- Søborg
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