Senior Regulatory Professional

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Are you an ambitious and science driven regulatory CMC professional who wants to work with innovative investigational medicines for the treatment of rare blood disorders and rare endocrine disorders? 

Are you able to take the lead and drive regulatory strategies for high impact projects and would you like to work together with decision makers and experts across multiple functions in a global environment?

Then this - Regulatory Affairs Professional – Late Stage Development role could be for you. 


The position
As a Regulatory professional in our area you are responsible for providing strategic input to projects, for developing global Regulatory CMC strategies, including: 

Being part of development projects, you will e.g. plan, coordinate and review the regulatory documentation in submission packages, responses to agency questions for global markets, and ensuring timely and efficient submissions of regulatory dossiers and plans to Health Authorities.
• Providing support and for execution of regulatory submissions for development projects and products throughout life cycle management. 
• Planning, coordinating and reviewing regulatory documentation e.g. supporting preparation of selected submission packages, responses to agency questions and Agency Meeting Packages. 
• You are expected to be a proactive leader, who is comfortable with challenging discussions and contributes to the project team. 

This position is based,Søborg, Capital area of Denmark. 

Qualifications
What we expect from you:
• M.Sc. and/or Ph.D. e.g. in Biochemistry, Pharmaceutical science or a similar university degree.
• At least 4 years of relevant experience from the pharmaceutical industry preferably including Regulatory CMC experience either from the pharmaceutical industry or from a medical agency. 
• A strong scientific and technical mindset, and a thorough understanding of related pharmaceutical operations (e.g. manufacturing, process development, analytics, and quality assurance).
• Ability to communicate topics related to protein chemistry/analytical chemistry/manufacturing of drug substances and drug products scientifically and professionally in your contact with colleagues and health authorities.
• High proficiency in written and spoken English


On a personal level you are:
• Curious to learn, well organised team player and a proactive problem solver 
• Focussed on project progression, can work independently and bring an innovative mindset seeking novel solutions to the challenges we face

About the department
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. In RA CMC Biopharm we are a group of 27 highly skilled and dedicated people divided into two departments and involved in every CMC aspect concerning our Biopharm and Haemophilia products. 
The project portfolio is rapidly evolving and therefore we are looking for a colleague with experience in regulatory CMC strategies for e.g. Advanced Therapy Medicinal Products (ATMPs), Monoclonal Antibodies and other protein-based biologics. 

Working with 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.

Moreover, at Novo Nordisk we recognise 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 the communities we operate in.

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


Senior Regulatory Professional

Are you an ambitious and science driven regulatory CMC professional who wants to work with innovative investigational medicines for the treatment of rare blood disorders and rare endocrine disorders? 

Are you able to take the lead and drive regulatory strategies for high impact projects and would you like to work together with decision makers and experts across multiple functions in a global environment?

Then this - Regulatory Affairs Professional – Late Stage Development role could be for you. 


The position
As a Regulatory professional in our area you are responsible for providing strategic input to projects, for developing global Regulatory CMC strategies, including: 

Being part of development projects, you will e.g. plan, coordinate and review the regulatory documentation in submission packages, responses to agency questions for global markets, and ensuring timely and efficient submissions of regulatory dossiers and plans to Health Authorities.
• Providing support and for execution of regulatory submissions for development projects and products throughout life cycle management. 
• Planning, coordinating and reviewing regulatory documentation e.g. supporting preparation of selected submission packages, responses to agency questions and Agency Meeting Packages. 
• You are expected to be a proactive leader, who is comfortable with challenging discussions and contributes to the project team. 

This position is based,Søborg, Capital area of Denmark. 

Qualifications
What we expect from you:
• M.Sc. and/or Ph.D. e.g. in Biochemistry, Pharmaceutical science or a similar university degree.
• At least 4 years of relevant experience from the pharmaceutical industry preferably including Regulatory CMC experience either from the pharmaceutical industry or from a medical agency. 
• A strong scientific and technical mindset, and a thorough understanding of related pharmaceutical operations (e.g. manufacturing, process development, analytics, and quality assurance).
• Ability to communicate topics related to protein chemistry/analytical chemistry/manufacturing of drug substances and drug products scientifically and professionally in your contact with colleagues and health authorities.
• High proficiency in written and spoken English


On a personal level you are:
• Curious to learn, well organised team player and a proactive problem solver 
• Focussed on project progression, can work independently and bring an innovative mindset seeking novel solutions to the challenges we face

About the department
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring rapid regulatory approval in all our markets. In RA CMC Biopharm we are a group of 27 highly skilled and dedicated people divided into two departments and involved in every CMC aspect concerning our Biopharm and Haemophilia products. 
The project portfolio is rapidly evolving and therefore we are looking for a colleague with experience in regulatory CMC strategies for e.g. Advanced Therapy Medicinal Products (ATMPs), Monoclonal Antibodies and other protein-based biologics. 

Working with 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.

Moreover, at Novo Nordisk we recognise 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 the communities we operate in.

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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