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Manager Affaires Réglementaires - CMC

Employer
NonStop Consulting
Location
Switzerland
Salary
Negotiable
Closing date
Feb 1, 2018

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Sector
Pharmaceutical, Regulatory Affairs
Contract Type
Employee
Hours
Full Time
Organization Type
Clinical Practice
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Job Details

RESPONSABLE AFFAIRES REGLEMENTAIRES CMC

Responsabilités

Assurer l'évaluation des documents réglementaire pour le maintien des AMM

Coordination de la rédaction des dossiers de variations (modules 2 et 3 du CTD)

Gestion des réponses aux autorités de santé

Profil du candidat
  • Pharmacien avec expérience de 4 ans minimum

    • Compétences clés

  • Maîtrise des référentiels (ICH, EMA, Pharmacopée Européenne), ainsi que des règles BPF
  • Connaissance réglementaire (rédaction de variation, CMC, Guidelines ICH, BPF)
  • Connaissance du développement pharmaceutique (analytique et / ou galénique)
  • Connaissance des techniques analytiques et / ou des procédés de fabrication

    • Demander à joindre le département Affaires Réglementaires France au 01 76 75 33 40

    ou Envoyer votre CV à l'adresse suivante : h.djilali@nonstop-pharma.com

    Company

    Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

    Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

    The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

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