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Regulatory CMC Director

Employer
NonStop Consulting
Location
Italy
Salary
Negotiable
Closing date
Apr 20, 2019

View more

Sector
Pharmaceutical, Regulatory Affairs
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate

Job Details

NonStop Pharma, on behalf of a well established and growing pharmaceutical company with worldwide operations, is currently looking for a Regulatory CMC Director with international responsibility.

The Director is responsible for leading Chemistry, Manufacturing and Control strategies for all products to be developed and commercialised from our client, at worldwide level. The role has an incredible goal: it will harmonise all processes at global level and will be the leader in the change the company is currently undertaking. It will liaise with all key functions at directional and project management level and will clearly leave a mark in the company's development for the next 10 to 15 years.

Key responsibilities:

  • Work closely with Regulatory Affairs team, R&D, Quality and Manufacturing
  • Critically review regulatory submissions and supporting documentation
  • Advise CMC functions on regulatory impact of potential manufacturing related changes
  • Review CMC aspects of drug labelling
  • Serve as a direct point of contact with health authorities for CMC issues
  • Manage, supervise and mentor junior members of the group
  • Drive the company forward at global level
  • Profile

  • Degree in scientific disciplines
  • Great to native level of English and Italian
  • 10 years or more in the pharmaceutical and/or devices industry with at least 5 years within CMC (site regs)
  • Superb leadership skills
  • Strong analytical and interpersonal skills
  • To apply, send an updated word format version of your CV, alongside the authorization to the use of personal data in accordance to the GDPR 679/16 - to Nicolandrea Menichini - n.menichini@nonstop-pharma.it

    NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

    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. 

    Company info
    Website

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