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    Regulatory Mature Product Leader Diabetology Job in Darmstadt, Germany

    Merck - with over 300 years of progress and about 38,000 employees in more than 60 countries, we are leading in Pharma, Chemicals and Life Sciences. With passion, commitment and innovative ideas, we are pursuing a global goal: to improve the quality of life for people.

    Regulatory Mature Product Leader Diabetology Job Description

    We are looking for a Mature Product Leader (m/f) who will be responsible and accountable for driving regulatory Life Cycle Management (LCM) projects and maintenance activities and serving as the Regulatory Affairs ambassador in project teams for Merck Serono’s Diabetology portfolio.

    The Director position will be based in Darmstadt.

    The incumbent will work very closely with all Regulatory Affairs functions as well as with R&D, Technical Operations and Commercial disciplines.

    Regulatory Mature Product Leader Diabetology Job Requirements

    • Degree in a Life Science or related discipline (minimum MSc degree), higher degree preferable (e.g.PhD in a scientific discipline)
    • Minimum of 8 years’ pharmaceutical industry experience, with 5 years’ global regulatory experience
    • Experience with clinical trial phase of development e.g. IND/CTA requirements
    • Development and preparation of successful regulatory strategies
    • Experience with LCM activities in at least two regions (e.g. Europe, USA)
    • Experience with NBEs and NCEs
    • Knowledge and practical experience in device and biomarker related regulatory requirements preferable
    • Practical experience in development in the Diabetes area preferable
    • Prior contribution to successful Health Agency Interactions
    • Experience as scientific advisor to several regulatory professionals as Regulatory Team Leader
    • In-depth knowledge of pharmaceutical legislation
    • Excellent written and spoken communication skills
    • Attention to details
    • Ability to think strategically
    • Ability to work in teams
    • Business orientation

    Regulatory Mature Product Leader Diabetology Application Information

    Please apply with your CV and cover letter by the 'apply' button below

    Remember - you found this opportunity on Qreer.com

    Regulatory Mature Product Leader Diabetology Summary

    Education Backgrounds: Biomedical Science
    Chemical Engineering
    Healthcare Science
    Specialties: (Bio) Chemistry
    Clinical Trial/Research
    Life sciences
    Pharmaceutics
    Education Level: Postgraduate (Masters)
    Doctorate (PH.D)
    Experience: 10 - 15 years
    5 - 10 Years
    > 15 years
    Languages spoken: English
    Job Location: Darmstadt, Germany

    Apply

    Merck

    Darmstadt, Germany
    HR Department
    +49 6151 720
    View Company Profile More Jobs with

    Type: Job

    Deadline: 12th February 2015

    Job reference (ID): 7168

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