Senior Regulatory CMC Professional for Life Cycle Management
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Søborg
Do you dream of a career with a global pharmaceutical company built on life-changing innovations? Does working with highly talented and engaged colleagues from many different professional backgrounds and cultures inspire you? Do you have a flair for setting and executing RA (Regulatory Affairs) strategies for product manufacturing process optimisations?
If yes, then you could be our new colleague in Regulatory Affairs. Apply now!
The position
We are looking for a colleague with scientific and technical mindset to work on late-stage development and Life Cycle Management (LCM) of our haemophilia and growth hormone disorders products. As a Senior Regulatory CMC (Chemistry, Manufacturing and Controls) Professional, you are expected to set strategic regulatory direction for global product roll out to markets and for manufacturing optimisation projects.
Your key responsibility is to ensure that scientific progress in turned into regulatory pathways. You will work closely together with decision-makers across multiple functions in a global environment, and you will thrive with the challenging reality of international communication across time zones, cultures, and circumstances.
In addition, you will also be responsible for and contribute to the success of RA CMC Biotech and Rare Disease by performing the following core tasks:
The role requires the ability to work effectively with people from different functions and organisational levels, calling for high cultural awareness and the necessary skills to encourage and influence colleagues, governance, and key stakeholders. This is an opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines and you can expect to build an extensive internal network.
We embrace remote work. Whether you prefer to work from home, at the Søborg office or to blend the two to your liking, we can make it possible.
Qualifications
What we expect from you:
As all work takes place in multidisciplinary project groups, we expect you to be a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills.
About the department
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring fast regulatory submissions and approvals in all our global markets. In RA CMC Biotech & Rare Disease we are a group of 40 highly skilled and dedicated regulatory professionals divided into three departments and involved in every Regulatory CMC aspect concerning our Rare and Other Serious Chronic Disease products. The LCM project portfolio is rapidly growing; therefore, we are looking for an experienced profile to join us and work in projects within protein-based biologics.
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 more information, please contact Philip Avnstrøm at +45 3077 7895.
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.
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.
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If yes, then you could be our new colleague in Regulatory Affairs. Apply now!
The position
We are looking for a colleague with scientific and technical mindset to work on late-stage development and Life Cycle Management (LCM) of our haemophilia and growth hormone disorders products. As a Senior Regulatory CMC (Chemistry, Manufacturing and Controls) Professional, you are expected to set strategic regulatory direction for global product roll out to markets and for manufacturing optimisation projects.
Your key responsibility is to ensure that scientific progress in turned into regulatory pathways. You will work closely together with decision-makers across multiple functions in a global environment, and you will thrive with the challenging reality of international communication across time zones, cultures, and circumstances.
In addition, you will also be responsible for and contribute to the success of RA CMC Biotech and Rare Disease by performing the following core tasks:
- Apply regulatory intelligence and develop global regulatory strategy to LCM projects
- Manage preparation of regulatory CMC file
- Drive submission of regulatory files, response to questions from health authorities and maintenance of marketing authorisation globally: MAA/NDA/BLA, CTA/IND, renewals, post approval changes, meeting request and meeting packages
- Support the planning and conduct of regulatory authority interactions and provide input to the preparation of meeting requests, meeting packages etc.
- Contribute to improvement projects
The role requires the ability to work effectively with people from different functions and organisational levels, calling for high cultural awareness and the necessary skills to encourage and influence colleagues, governance, and key stakeholders. This is an opportunity for you to continue your individual development and stay updated within relevant regulatory and biotech disciplines and you can expect to build an extensive internal network.
We embrace remote work. Whether you prefer to work from home, at the Søborg office or to blend the two to your liking, we can make it possible.
Qualifications
What we expect from you:
- 5-7 years of relevant experience from the pharmaceutical industry
- A strong scientific and technical mindset, as well as a thorough understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytics, and quality assurance)
- Ability to communicate topics related to CMC of drug substances and drug products scientifically and professionally in your contact with colleagues and health authorities
- High proficiency in English
As all work takes place in multidisciplinary project groups, we expect you to be a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills.
About the department
Novo Nordisk Regulatory Affairs makes medicine available to patients all over the world by ensuring fast regulatory submissions and approvals in all our global markets. In RA CMC Biotech & Rare Disease we are a group of 40 highly skilled and dedicated regulatory professionals divided into three departments and involved in every Regulatory CMC aspect concerning our Rare and Other Serious Chronic Disease products. The LCM project portfolio is rapidly growing; therefore, we are looking for an experienced profile to join us and work in projects within protein-based biologics.
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 more information, please contact Philip Avnstrøm at +45 3077 7895.
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.
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.
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 2.12.2022, 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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