Regulatory Affairs CMC Expert - Early Development

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Søborg

Are you passionate about drug development within Biologics and Rare Disease? Do you want to take the lead and set direction and be our Regulatory Affairs Expert in biologics? Then this might be the job you are looking for. Join our Regulatory Affairs CMC Biotech & Rare Disease (BRD) team, apply today! The position As a Regulatory Affairs CMC Expert, you will act as RA CMC lead for biologics (affibodies) in early development projects and are expected 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 and build partnerships with key stakeholders from other functions internally as well as external partners. You will also provide strategic, tactical, and operational regulatory input to projects. In addition, you will also be responsible for and contribute to the success of RA CMC BRD by:
  • 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

  • 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

  • Contributing to improvement projects

    • 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 To thrive in this role, you hold a Master and/or Ph.D. degree in life sciences and have:
  • Extensive experience working with biologics

  • Broad understanding of global drug development

  • In-depth knowledge of regulatory requirements for CTA’s and/or BLA’s

  • 5 – 8 years of global regulatory experience in obtaining product licenses in the EU, US and other major countries from pharmaceutical industry or health authority

  • Experience of interacting with key regulatory authorities e.g. FDA, EMA, PMDA, and scientific advisory meetings

    • You have experience with navigating within an environment of tight timelines, high-complexity, non-standards and diverse tasks in known and new therapy areas. Moreover, you possess excellent analytical skills, systematic approach to identify root causes and propose innovative ways to solve problems. You can communicate complex scientific procedures with technical proficiency both orally and in writing. An advanced level in written and spoken English is a prerequisite. 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 Affairs CMC Expert to join us and work on biologics projects. 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 Ana Mora Agudo +45 3075 0292. Deadline 15th of August 2023. Candidates will be evaluated and interviewed on an ongoing basis, so do apply at the earliest. As we have several open positions in Regulatory Affairs, managers from other departments might get access to your application. Please submit an English version of your resume and include a few sentences about your motivation towards this position. 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. 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 6.7.2023, men kan have været deaktiveret og genaktiveret igen.

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    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • Øvrige
    • Søborg
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