Regulatory Affairs Specialist for projects in clinical development

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Søborg

Are you passionate about regulatory science and driving innovative regulatory strategies to bring innovative medicines to patients across multiple therapy areas? Do you have a strong scientific background combined with regulatory drug development experience? If yes, then we invite you to submit your application and become an integral part of a team dedicated to a high-profile project within Regulatory Affairs (RA). We are currently expanding as our projects progress rapidly into phase II development in multiple indications. Take the next step and apply now! The position We are expanding our team with a Regulatory Affairs Specialist who will play a pivotal strategic role in advancing the development of patient-focused medicines, with the aim of accelerating the acquisition of Marketing Authorisations from regulatory authorities worldwide. As a Regulatory Affairs Specialist, you will be responsible for driving several regulatory tasks with challenging and often overlapping timelines for our development projects. This position requires close collaboration with the Global Regulatory Lead to shape the regulatory strategy. Additionally, it necessitates engagement with stakeholders from project management, medical and non-clinical experts, statisticians, and medical writers. Your key responsibilities will include:
  • Develop regulatory strategies within new therapy areas
  • Provide strategic input and regulatory expertise to the overall project development plan and organisation; also evaluate project risks and recommend regulatory mitigations
  • Participate in strategic project dialogues, challenging discussions, and influencing critical business decisions
  • Identify and implement innovative opportunities to accelerate development, seek solutions and achieve desired outcomes
  • Contribute to initiatives aimed at optimising regulatory processes across the organisation
  • Mentor junior colleagues and share your expertise to support their professional development
    • Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site work in Søborg, Denmark where our team is based. Qualifications
    To succeed in this role, we expect you to have:
  • An academic degree such as a Master's degree and/or a Ph.D. within Life Science, Health Science or a related field
  • Extensive Regulatory Affairs experience (6-7 years) within drug development
  • Proven track record of interacting directly with regulatory authorities on an international scale
  • Strong negotiation skills and a sound understanding of business and data
  • Proficiency in written and spoken English
    • On a personal level, you thrive in collaborative team settings, demonstrating strong leadership and contribution to team achievements. You should exhibit excellent organisational skills, robust problem-solving abilities, and maintain a strategic focus. A positive, can-do attitude is essential, along with the capacity to maintain composure and a sense of humour in high-pressure situations. Proficiency in effective communication to facilitate collaboration across all organisational levels is highly valued. About the department RA Diabetes and Obesity Development Projects consists of 24 dedicated and highly engaged regulatory leads, specialists, and regulatory professionals, organised into three teams. We are currently managing multiple active projects that span a wide array of domains and functional areas. Our department is charged with delivering and executing on global regulatory strategies. These strategies are designed to advance projects across multiple indications, from the early stages of development through to worldwide submission and approval of initial Marketing Authorisation applications. We are responsible for driving label development, facilitating interactions with health authorities, and overseeing regulatory submissions. These submissions include initial marketing authorisation applications, paediatric plans, and clinical trial applications. We maintain strong ties with our affiliates and global stakeholders, fostering a close collaboration that is integral to our operations. 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 to manufacturing, marketing, and sales – we’re all working to move the needle on patient care. Contact For further information, please contact David Truloff at +45 30790499. Deadline 05 November 2023. Please note we will invite candidates for interviews on an ongoing basis and conclude the recruitment process when the right candidate has been found. You do not need to attach a cover letter to your application, but please include a few lines about your motivation in your resume or CV. Please assist us in maintaining a fair and inclusive selection process by not attaching a photo to your application. 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 19.10.2023, 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.
    • Apoteker
    • Søborg
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