Regulatory Planning Partner
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Søborg
Do you enjoy balancing multiple input - data, priorities, global stakeholders and constraints from a regulated environment?
We have a great opening to join a new team that will be responsible for driving optimised and timely submission plans towards our affiliates – ensuring optimised and increased flexibility within our growing manufacturing network. Apply now for our Regulatory Planning Partner role!
The position
The role is new within the department where you will have individual area of responsibility and will support the specific organisational setup within our manufacturing organisation. You will be responsible for submission planning of global roll outs of life cycle management variation – enabling our HQ Regulatory Affairs function to support affiliates with realistic, transparent plan and reliable plans towards stakeholders.
The position requires analytical skills ability to create good plans, being focused on a high-level reporting of both details and a management friendly summary conveyed in a simple and professional way. An increased focus is needed to follow up and provide tactical planning with all affiliates across the world for life cycle management changes, submission of a new manufacturing site or an optimised process in manufacturing.
Your main tasks will include:
The team and the Regulatory Planner Partner role, as well as the submission planning process will be optimised during the coming years. You will have the opportunity to be part of the transformational journey, projects establishing new LCM (Life Cycle Management) processes, supporting IT solutions and tools for both planning and proactive submission planning.
Qualifications
To be successful in this role, you need the following:
On a personal level, you need to be dedicated team player, can build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills.
About the department
Novo Nordisk Regulatory Affairs is responsible for making medicine available to patients all over the world by ensuring fast regulatory submissions and approvals in all our global markets.
You will be part of a relatively new department responsible for project management, scientific and regulatory strategic input to capacity and manufacturing projects, as well as being responsible for enabling fast approvals for world-wide roll-out and return on investment for the growing manufacturing network, by supporting our HQ colleagues and the affiliates with transparent and tactical planning and execution of submissions.
Our primary stakeholders are the global manufacturing sites, as well as central Supply Chain areas. We are engaged in high potential projects to support the demand of increasing capacity and flexibility in our global manufacturing network and implement newest technology.
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 more information, please contact Malene Østergaard Jørgensen at +45 3079 5844.
Deadline
02 January 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline.
We are looking for several Regulatory Affairs profiles at Novo Nordisk now. Therefore, hiring managers from different teams might also look at your application.
Please briefly explain what motivated you to apply for this role. Include your statement either in CV or Cover Letter, if there is one. 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.
Print job Send to e-mail
We have a great opening to join a new team that will be responsible for driving optimised and timely submission plans towards our affiliates – ensuring optimised and increased flexibility within our growing manufacturing network. Apply now for our Regulatory Planning Partner role!
The position
The role is new within the department where you will have individual area of responsibility and will support the specific organisational setup within our manufacturing organisation. You will be responsible for submission planning of global roll outs of life cycle management variation – enabling our HQ Regulatory Affairs function to support affiliates with realistic, transparent plan and reliable plans towards stakeholders.
The position requires analytical skills ability to create good plans, being focused on a high-level reporting of both details and a management friendly summary conveyed in a simple and professional way. An increased focus is needed to follow up and provide tactical planning with all affiliates across the world for life cycle management changes, submission of a new manufacturing site or an optimised process in manufacturing.
Your main tasks will include:
- Driving clear priorities and optimised plans, to support the specific needs within your organisational area of responsibility
- Partnering up with Supply Chain, supporting both long, mid- and short-term planning, entailing both reliable plans for long term utilisation of the network
- Focusing on planning of submissions and approvals
- Close collaboration with product responsible leads and teams in Regulatory Affairs (RA) Chemistry Manufacturing Control (CMC) & Device
- Following up with regional offices and affiliates
The team and the Regulatory Planner Partner role, as well as the submission planning process will be optimised during the coming years. You will have the opportunity to be part of the transformational journey, projects establishing new LCM (Life Cycle Management) processes, supporting IT solutions and tools for both planning and proactive submission planning.
Qualifications
To be successful in this role, you need the following:
- Master’s degree in Supply Chain Management, Business Administration or any other field of study
- Minimum 3 years of experiences from a position being responsible for planning in an ever-changing environment
- Project management track record
- Hands-on experience navigating within an environment of tight timelines, high complexity, non-standards, and diverse tasks in known and new therapy areas
- Advanced level of written and spoken English is required
On a personal level, you need to be dedicated team player, can build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills.
About the department
Novo Nordisk Regulatory Affairs is responsible for making medicine available to patients all over the world by ensuring fast regulatory submissions and approvals in all our global markets.
You will be part of a relatively new department responsible for project management, scientific and regulatory strategic input to capacity and manufacturing projects, as well as being responsible for enabling fast approvals for world-wide roll-out and return on investment for the growing manufacturing network, by supporting our HQ colleagues and the affiliates with transparent and tactical planning and execution of submissions.
Our primary stakeholders are the global manufacturing sites, as well as central Supply Chain areas. We are engaged in high potential projects to support the demand of increasing capacity and flexibility in our global manufacturing network and implement newest technology.
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 more information, please contact Malene Østergaard Jørgensen at +45 3079 5844.
Deadline
02 January 2023. Applications will be evaluated continuously when received and candidates may be called for interview before the deadline.
We are looking for several Regulatory Affairs profiles at Novo Nordisk now. Therefore, hiring managers from different teams might also look at your application.
Please briefly explain what motivated you to apply for this role. Include your statement either in CV or Cover Letter, if there is one. 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.
Print job Send to e-mail
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 24.11.2022, 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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