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Regulatory Affairs Manager, Development

Employer
NonStop Consulting
Location
Lugano
Salary
£46236 - £77060 per annum + Negotiable
Closing date
Sep 20, 2019

View more

Sector
Pharmaceutical, Regulatory Affairs
Contract Type
Employee
Hours
Full Time
Organization Type
Clinical Practice
Jobseeker Type
Professional

Job Details

Regulatory Affairs Manager, Development, Strong Pipeline and Established Products, Opportunity to be involved in FDA submissions, Lugano Switzerland, Global Team

Looking to further expand your responsibilities in pre-approval submissions?

I am working with an innovative pharmaceutical company who are approaching a number of key approvals over the next few years. Due to this, we are looking for an experienced regulatory professional to help lead new portfolio products covering PIPs, CTAs, CMC and scientific advice. Key points that make this role attractive are that the RA team shares both pre and post approval activities. Because of this, you will get a mixture of tasks across commercial regulatory as well as developmental.

If you could be interested in 'principle', then please contact me.

Key responsibilities:

  • Lead regulatory strategy and processes for certain portfolio products
  • Input towards areas such as scientific advice, HA meetings, CTAs, PIPS and CMC
  • Involvement in LCM activities
  • Work as part of the general EU/FDA and international regulatory affairs team

Key requirements:

  • Fluency in English
  • Over 3 years experience in regulatory affairs for pharmaceuticals
  • Experience in EMA Rx submissions for pre-approval, ideally US or Swissmedic experience.
  • Life science degree
  • Currently located in Switzerland or Europe

For a confidential discussion about this role, or to apply, then send your CV to m.beedle@nonstop-recruitment.com or call me, Matt Beedle, Executive Partner on +41435 080817. Please feel free to visit my linked-in profile to see my references/recommendations.


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, Luxembourg, Switzerland, Romania, the US 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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