Regulatory Affairs CMC Expert, Early Development
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Søborg
Are you curious about drug development within Rare Disease, willing to take the lead and set strategic direction in projects? Would you like to be part of the expansion of our product pipeline in Novo Nordisk? If yes, you could be our new Regulatory Affairs CMC Expert in Early Development. Apply now for a life-changing career! The position
As a Regulatory Affairs CMC Expert, you are expected to demonstrate leadership by setting strategic direction for biologics and synthetic peptide analogues in early development, and to drive scientific and regulatory discussion across our portfolio. You will be working closely together with decision-makers across multiple functions in a global environment, thriving with the challenging reality of international communication across time zones, cultures, and circumstances. In addition, your main responsibilities will include:
• Applying regulatory intelligence and establish strategy for submission of Clinical trial applications, and Marketing authorisation
• Drive submission of regulatory files, response to questions from health authorities
• Ensuring compilation, review, and submission of pre-meeting packages for authority meetings; conducting rehearsals and participate in meetings
• Building partnerships with key stakeholders from other functions internally and external partners.
• Addressing dilemmas and analyse complex challenges to propose new ways to support projects with regulatory expertise
• Facilitating the regulatory approval process by identifying key risks and ensure timely, complete, and high-quality answers to authority questions 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 role offers an opportunity for you to continue your individual development and connect your scientific knowledge to the regulatory framework of CMC in benefit of the patients. The atmosphere is informal and good humour is always welcome. Our commitment to innovation also applies to the way we work - we embrace a flexible workplace, with a blend of in-office and remote work. Qualifications
To be a great asset to our team, you will have:
• A MSc or PhD degree in Life Sciences
• At least, 5 years of relevant experience in Regulatory and/or CMC either from the pharmaceutical industry or from a healthy authority
• Broad understanding of global drug development and knowledge of regulatory requirements
• Experience interacting with key regulatory authorities (FDA, EMA, PMDA) and obtaining product licenses in the EU, US and other major countries.
• Experience of navigating within an environment of tight timelines, high-complexity, non-standards, and diverse tasks in known and new therapy areas As a person, you have excellent analytical skills and a systematic approach to identify root causes and propose innovative ways to solve problems. You have the ability to communicate complex scientific procedures with technical proficiency both orally and in writing. 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 45 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 project portfolio is rapidly growing; therefore, we are looking for a Regulatory Specialist to join us. 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 +45 3077 7895 Deadline
18 June 2023
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.
As a Regulatory Affairs CMC Expert, you are expected to demonstrate leadership by setting strategic direction for biologics and synthetic peptide analogues in early development, and to drive scientific and regulatory discussion across our portfolio. You will be working closely together with decision-makers across multiple functions in a global environment, thriving with the challenging reality of international communication across time zones, cultures, and circumstances. In addition, your main responsibilities will include:
• Applying regulatory intelligence and establish strategy for submission of Clinical trial applications, and Marketing authorisation
• Drive submission of regulatory files, response to questions from health authorities
• Ensuring compilation, review, and submission of pre-meeting packages for authority meetings; conducting rehearsals and participate in meetings
• Building partnerships with key stakeholders from other functions internally and external partners.
• Addressing dilemmas and analyse complex challenges to propose new ways to support projects with regulatory expertise
• Facilitating the regulatory approval process by identifying key risks and ensure timely, complete, and high-quality answers to authority questions 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 role offers an opportunity for you to continue your individual development and connect your scientific knowledge to the regulatory framework of CMC in benefit of the patients. The atmosphere is informal and good humour is always welcome. Our commitment to innovation also applies to the way we work - we embrace a flexible workplace, with a blend of in-office and remote work. Qualifications
To be a great asset to our team, you will have:
• A MSc or PhD degree in Life Sciences
• At least, 5 years of relevant experience in Regulatory and/or CMC either from the pharmaceutical industry or from a healthy authority
• Broad understanding of global drug development and knowledge of regulatory requirements
• Experience interacting with key regulatory authorities (FDA, EMA, PMDA) and obtaining product licenses in the EU, US and other major countries.
• Experience of navigating within an environment of tight timelines, high-complexity, non-standards, and diverse tasks in known and new therapy areas As a person, you have excellent analytical skills and a systematic approach to identify root causes and propose innovative ways to solve problems. You have the ability to communicate complex scientific procedures with technical proficiency both orally and in writing. 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 45 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 project portfolio is rapidly growing; therefore, we are looking for a Regulatory Specialist to join us. 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 +45 3077 7895 Deadline
18 June 2023
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 Søborg.
Jobbet er oprettet på vores service den 11.5.2023, 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.
- Øvrige
- Søborg
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