Regulatory Affairs CMC Professional

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Søborg

We are expanding our product and project pipeline in Novo Nordisk and are looking for engaged RA CMC Specialists to join RA CMC Biotech & Rare Disease (BRD) in Novo Nordisk Global Regulatory Affairs unit. If you are curious about drug development within Rare and Other Serious Chronic Diseases, willing to take lead, set strategic direction in projects and be a regulatory affairs expert in a growing organization this might be the job you are looking for. The position We are looking for a Regulatory Professional for Life Cycle Management, Late-stage Development projects within Rare and Other Serious Chronic Diseases. As a Regulatory CMC professional working with biologic products in late-stage development and life cycle management, you are expected to the set strategic regulatory direction for global product roll out to markets and for manufacturing optimisation.
In this role you will be working closely together with decision-makers across multiple functions in a global environment, you thrive with the challenging reality of international communication across time zones, cultures, and circumstances. Your key responsibility is to ensure that scientific progress in turned into regulatory pathways and you will also be responsible for submission planning including applying intelligence and develop regulatory CMC strategy In addition, you will also be responsible for and contribute to the success of RA CMC BRD by:
  • Responsible for preparation and maintenance of regulatory files
  • Responsible for submission of regulatory CMC files, response to questions from health authorities and maintenance of marketing authorizations globally, e.g.:
    • MAA/NDA/BLA, NBOp, CE, CTA/IND, Device File, Site Master File, renewals, post approval changes and commitments

  • Responsible for planning and conducting of regulatory interactions with health authorities including preparation of meeting requests, meeting packages, rehearsal and taking minutes of formal meetings
  • Provide input to affiliates for preparation for health authority interaction
  • Represent RA function in RA matrix team, ensuring alignment of planning and strategy across areas including affiliates
    • The roles require 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. Our commitment to innovation also applies to the way we work: We embrace remote work and the hybrid workplace. Whether you prefer to work from home, at the office or to blend the two to your liking.Qualifications You hold a Master’s degree with typically some relevant working experience and/or PhD, both within some of the below qualifiers or bachelor’s degree with typically 4-7 years of relevant experience within some of the below qualifiers. What we expect from you:
  • 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 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. Working at Novo NordiskAt 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 for application 23 June 2023. Please note that applications are screened on an ongoing basis, so you are encouraged to apply as soon as possible.Please include a few sentences about why you are applying for this position, 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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    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 31.3.2023, men kan have været deaktiveret og genaktiveret igen.

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    • Øvrige
    • Søborg
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