Senior Regulatory Affairs & Pharmacovigilance Manager

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Ørestad

Looking for a challenging and rewarding opportunity? We are looking for a Senior Regulatory Affairs & Pharmacovigilance Manager to join our newly established department in Region North West Europe (NWE). If you thrive in a fast-paced environment and have professional authority in all interactions with internal and external stakeholders, then this is your cue to apply! The Position Based in Copenhagen, Denmark, you will report to the Region NWE Regulatory Affairs Director and become a valued member of the Region NWE Clinical, Medical & Regulatory (CMR) team. As a seasoned professional, you will play a crucial role in our transformative journey. As Senior Regulatory Affairs & Pharmacovigilance Manager you will support driving the function across Region NWE to ensure that the strategic direction supports NWE’s commercial success by delivering timely regulatory approvals with optimal product claims as well as enabling optimal launch conditions for new products and life cycle management improvements on current products across Region NWE; you will provide regulatory support to regulatory function in affiliates and key counterparts to ensure Region NWE’s commercial success in alignment with Region NWE, International Operations (IO) and corporate strategy & priorities. Moreover,
  • You will be a member of global regional regulatory lead and represent Regional RA towards regional & global counterparts and external stakeholders and contribute to set strategic direction for the Regulatory Affairs function across Region NWE.
  • You will simplify and align regulatory processes and systems across Region NWE in collaboration and alignment with IO & HQ.
  • You will contribute to and drive the successful implementation of strategic IO PV initiatives, while ensuring that implementation is followed by effective maintenance and oversight.
  • You will spearhead the alignment and optimization of Pharmacovigilance (PV) processes across Region NWE. You will also identify opportunities for alignment and facilitate effective best practice sharing within Region NWE, IO, with external partners, and between IO and Head Quarter Global Safety.
  • You will act as a trusted advisory resource for stakeholders spanning regions and affiliates across Region NWE. You will be the expert on Region NWE RA and PV initiatives, processes, and requirements, fostering compliance and cohesion.
    • Qualifications You hold a master’s degree in life sciences, with a focus in medical, pharmaceutical, or biological sciences. With over five years of experience in the bio/pharmaceutical industry and two years of experience in the RA & PV domain, you have developed a deep understanding of the industry and are well-equipped to hit the ground running in this role. You also possess:
  • Broad hands-on experience in RA PV, ideally from a global or affiliate position, which will enable you to hit the ground running and make an immediate impact.
  • Good knowledge of the international regulatory requirements and pharmacovigilance principles. As well as sound business understanding, which will enable you to align RA and PV strategies with broader business goals and drive results.
  • Strong project management skills and sound business understanding enabling RA strategy
  • Good knowledge of the business processes required for establishing PV contracts/agreements with external parties.
  • Experience working in international and diverse professional groups.
  • A good understanding of the pharmaceutical industry value chain, which will enable you to identify opportunities for growth and innovation and make data-driven decisions that drive success.
    • About the Department Region North West Europe (NWE) is the largest region of International Operations in terms of turnover. We have around 2000 colleagues of which 100+ work for the Regional Office based in Ørestad, Copenhagen. Together we are all committed to step ahead and set the pace for better outcomes for patients and societies in the region. 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 If you have any questions, please contact Golshid Tondravi, Regulatory Affairs Director, Region NWE ([email protected]). Deadline Apply before 8th March but kindly send your application as soon as possible as job interviews will be held ongoing to ensure a quick process. You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or 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 Ørestad.

    Jobbet er oprettet på vores service den 24.1.2024, men kan have været deaktiveret og genaktiveret igen.

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