Regulatory Affairs Director - Lifecycle Portfolio Management

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As the Lifecycle Portfolio Director within the International Operations Strategic Operations (IO-SO) Clinical, Medical, and Regulatory (CMR) unit, you'll steer regulatory innovation, pioneering strategies that secure approvals and pioneer healthcare advancements across borders. You will collaborate closely with cross-functional teams including senior management levels, across the globe, transforming challenges into opportunities, driving initiatives that redefine supply flexibility, ensuring global access to life-changing treatments. The Position As the Regulatory Affairs Director in this pivotal role, you'll be at the forefront of regulatory leadership and strategic innovation. Your responsibilities will revolve around:
  • Life Cycle Management: Strategically leading regulatory approaches for Marketing Authorization maintenance across International Operations, prioritizing business continuity and amplifying the RA portfolio's value.
  • Supply Flexibility Initiatives: Driving targeted initiatives to enhance market access and mitigate risks through adept Life Cycle Management practices.
  • Revamping Regulatory Framework: Collaborating with Head Quarter functions to implement cutting-edge frameworks, processes, and IT systems for life cycle management submissions and approvals.
  • Effective supply imbalances management: Overseeing and addressing drug shortages within IO, ensuring alignment among diverse functions and readiness at regional levels.
  • Stakeholder Engagement and Influence: Engaging with critical internal stakeholders like IO-SO-CMR, Regional Regulatory Leads, Global Regulatory Affairs, Commercial teams and Product Supply. Your role will involve influencing and effectively communicating regulatory strategies and updates across the extensive International Operations landscape, covering NWE, Germany, China, Japan, SEEMEA, APAC and LATAM regions.
    • Qualifications To be successful in this position you will possess a robust educational background, a wealth of industry experience, and a diverse skill set. Specifically:
  • Education & Experience : A university degree in Pharmaceutical, Medical Science, or a related field, complemented by a postgraduate degree like a PhD, MBA, or MSc. A minimum of 5 years in strategic international regulatory roles and at least 8 years within the pharmaceutical industry is essential.
  • Skills Proficiency: Proven expertise in project management, comprehensive knowledge of Regulatory Affairs (RA), and impeccable execution abilities are prerequisites. Fluency in English is mandatory for effective communication in this global context.
    • Personal Attributes:
  • Exceptional strategic planning and execution skills.
  • Leadership qualities to direct teams and foster collaboration.
  • Outstanding stakeholder management and a global perspective.
  • Deep insights into the pharmaceutical business landscape.
  • Regulatory intelligence covering submission and approval processes.
    • About the Department Headquartered in Zurich, International Operations (IO) covers 22 time-zones and has more than 16,000 employees around the world working passionately to change over 29 million patients’ lives each day. As a key driver of Novo Nordisk’s growth, and a geographical scope of 7 Regions covering 193 countries, IO offers a dynamic environment and a world of opportunities. This position is based in the IOSO-Hub in Orestaden, Copenhagen-DK, joining approximately 50 IOSO colleagues, including IOSO Regulatory Affairs and Pharmacovigilance team members. 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 Regulatory Affairs & PV Vice President, Cesar Miglioranzza at [email protected]. Deadline Apply before 30th November 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.


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    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 20.11.2023, men kan have været deaktiveret og genaktiveret igen.

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