US Regulatory Affairs Manager
- Employer
- NonStop Consulting
- Location
- Cambridge
- Salary
- USD110000 - USD160000 per annum
- Closing date
- Mar 9, 2021
View more
- Sector
- Science, Life Sciences, Anatomy/Physiology
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
Job Details
Role: US Regulatory Affairs Manager
Location: Cambridge, MA/ New York
A small and innovative nanomedicine company is looking for a Senior Regulatory Affairs specialist. Our client is a late clinical stage company with expertise in Immune-Oncology.
Based in Cambridge, MA , US Regulatory Affairs Manager role will be focused on management of number of regulatory processes, communicate with authorities (FDA) and being able to help develop and implement strategy to ensure the exciting lead product gets to market as quickly as possible.
Requirements:
- 5 years of regulatory experience in drug development/ biotech/pharma industries
- Experience with FDA
- Advanced degree in a scientific major
- Regulatory Affairs Certification - strong advantage
- Experience in Oncology - strong advantage
Role:
- Developing regulatory strategies
- Interfacing with Regulatory agencies
- Controlling the quality of submissions
- Managing the regulatory intelligence to ensure the Company regulatory compliance, from the development phases to the products end of life
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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