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Global Regulatory Affairs - CMC

Employer
NonStop Consulting
Location
Copenhagen
Salary
€90000 - €100000 per annum
Closing date
Nov 6, 2018

View more

Sector
Science, Life Sciences, Cell and Molecular Biology
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional

Job Details

Global Regulatory Affairs Professional -CMC BioPharma


Have you worked with regulator life-cycle management activities for biological products? then i have just the opportunity for you!

You will be Regulatory responsible for our global regulatory activities throughout the life cycle of our products growing portfolio, including development and registration as well as market expansions and CMC lifecycle activities in 50 countries worldwide.

You will be joining a growing team of 17 dedicated colleagues with high ambitions, there will help you grow and form the company on this new challenging journey as they start up scaling the company to take on new unique challenges , so if you like working in a growing company where you have to be ready to take on new challenges and help define the companies structure, then this is a unique opportunity for you!

The Position
- reporting to the Head of Regulatory Affairs
  • Planning, coordinating and executing global regulatory submission activities for assigned products
  • Writing, compiling and reviewing regulatory CMC submissions
  • Provide regulatory CMC expertise to colleagues the company
  • Perform regulatory impact assessment of CMC change controls; ensure adequate documentation is generated to support the change and that the variation is approved by regulators worldwide
required experience
  • relevant degree in life science or pharmacy
  • 2-3 years of experience working with Pharma regulatory affairs ideally within CMC of biologics.

Preferred



  • Experience collaborating with EMA and FDA
  • Experience with filling of NDA and MAA

If you are interested, then get in touch with, Casper Skyum Hogh by applying below.
You can also connect with me on LinkedIn and send your Cv to me in a word format on the email found on my profile or find more opportunities that we have available on Nonstop's website

I am a specialised recruiter within Regulatory affairs and medical affairs in the Pharma, Biotech and Medical Device industry. I, therefore, have access to an extensive network within these industries, which aren't available otherwise. If the above opportunity doesn't have your interest, but you would like to hear more about potential opportunities, then you are welcome to contact me for a noncommittal, confidential chat.

If you know someone in your network who may be interested in the above, then you are more than welcome to pass on my details to them, so that I can be of assistance to them.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech 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 for all EU8 countries. 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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