Regulatory Affairs CMC Experts

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Søborg

We are rapidly expanding our product and project pipeline in Novo Nordisk and are looking for experienced Regulatory Affairs CMC Experts to join RA CMC & Device – a part of Novo Nordisk's Development organization. If you are passionate about drug development within chronic and rare diseases and want to be a subject matter expert in a leading international organization, then this might be the job for you. You will have the opportunity to take the lead and set the strategic direction in projects of crucial importance to Novo Nordisk’s growth on a global level. About the department Novo Nordisk Regulatory Affairs makes medicine available to patients around the world by ensuring fast regulatory submissions and approvals in all our global markets. The RA CMC Diabetes & Obesity and Biotech & Rare Disease areas consist of just over 100 highly skilled dedicated colleagues with very diverse backgrounds and experience, who are involved in every Regulatory CMC aspect concerning products and projects in these areas. The position As a RA CMC Expert, you will have the opportunity to work within early-stage development, late-stage development and/or life cycle management – depending on your experience and area of interest. Novo Nordisk is expanding its product portfolio, which requires highly diverse CMC solutions due to the complex manufacturing processes. You can therefore work with different product modalities - biologics, small molecules, ATMPs, siRNAs, etc. – in a variety of therapeutic areas – including among others diabetes, obesity, and rare diseases. Your primary responsibility will be to ensure that scientific progress is turned into regulatory pathways, through a close collaboration with key decision-makers across functions on a global level. With your subject matter expertise, you will contribute to the success of RA CMC by driving regulatory CMC submissions to health authorities worldwide within your specific area/s. More specifically, you will be accountable for:
  • Planning of regulatory CMC submissions - applying intelligence and developing regulatory strategy
  • Preparation and maintenance of regulatory files
  • Submission of regulatory files, response to inquiries from health authorities and maintenance of marketing authorizations globally – e.g., MAA/NDA/BLA, CTA/IND, Site Master File, renewals, post approval changes and commitments
  • Planning and conducting of regulatory interactions with authorities and Novo Nordisk affiliates
    • This role will 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 therefore embrace the hybrid workplace – with a blend of home office and on-site work preferably in Søborg, Denmark where the global RA CMC & Device department is based. Qualifications The ideal amount of work experience for this role varies according to your educational background. If you hold a master’s degree, we expect you to typically have more than 8 years of relevant experience. With a PhD, at least 5 years are expected. You should typically have a minimum of 10 years of relevant experience if you hold a bachelor’s degree. You come with a strong scientific and technical background and mindset, which you have acquired through your extensive experience with RA CMC and/or pharmaceutical operations – manufacturing, product supply, process development, CMC development, analytics, quality assurance and other related areas. As all work takes place in multidisciplinary project groups, you are a dedicated team player, find it easy to build working relationships, and gain recognition amongst stakeholders with your proactiveness, integrity, and communication skills. Furthermore, you thrive in the challenging reality of international communication across time zones and cultures, and you have a high proficiency in English - written as well as spoken. Visit our Regulatory Affairs Careers webpages For more information about job content and qualifications, please visit the Novo Nordisk Regulatory Affairs Careers webpages at https://www.novonordisk.com/careers/career-areas/research-and-development/regulatory-affairs-careers.html Working at Novo Nordisk At Novo Nordisk, we do not wait for change. We drive it. We are 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 are all working to move the needle on patient care. Contact You are welcome to contact Ana Mora Agudo at [email protected] or Samantha Donslund Schwab at [email protected] for further information. Deadline for application As we are looking for several Regulatory Affairs CMC Experts to join us over the coming year, this job ad will be posted for an extended period (max 6 months starting October 11th 2023). If you are interested in this role, please apply as soon as possible. Applications will be evaluated on an ongoing basis, so there may go some time before you hear from us. 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.


    Information og data

    Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 11.10.2023, men kan have været deaktiveret og genaktiveret igen.

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