Regulatory Affairs Manager! Grow in pharma!
- Employer
- NonStop Consulting
- Location
- New York
- Salary
- USD100000 - USD110000 per annum + NEGOTIABLE
- Closing date
- Jun 25, 2016
View more
- Sector
- Pharmaceutical, Regulatory Affairs
- Contract Type
- Employee
- Hours
- Full Time
- Organization Type
- Corporate
- Jobseeker Type
- Professional
Job Details
My client is looking for a candidate for covering a role as a Regulatory Affairs Manager in it's headquarters located in NY ASAP. The candidate will need an experience of minimum 3 years in Regulatory Affairs (within the Pharmaceutical industry) with focus on ANDA, eCTD, NDA and IND submissions.Some of your responsibilities will be being the main contact point with regulatory authorities in US and Canada for communications relating to assigned projects/products.
Reviewing promotional and scientific information, according to local requirements and codes.
Interacting, as needed, with internal functions, consultants and external CROs, in preparing, submitting and maintaining regulatory applications, participating in industry committees and writing of white papers, critiques or commentaries that represent our perspective on e.g. draft ICH, and FDA guidance documents related to the development projects.
Supporting the relevant functions for GXP inspections relevant to development projects.
You will work directly under the line manager, a luminar in regulations, who will be able to teach you, improving even more your knowledge. Furthermore the company is one of the few who are investing great part of their final revenue on the development of new products designed for rare diseases, which makes the job even more interesting and stimulating for a person involved in regulations.
In the end the dynamic environment surrounding you will allow you to learn, grow your experience and subsequently grow professionally within a relatively short period of time.
What we are looking for:
- 3 years experience within the Regulatory Affairs field (mandatory)
- previous experience within the Pharmaceutical company
- experience in post-marketing regulations (ANDA,eCTD,NDA,IND)
- US citizen
- proactive character
- will to grow professionally in a dynamic environment
- positive attitude
What we offer:
- competitive salary
- permanent contract
- professional growth
- responsibility and visibility
- highly qualified and specialized environment
- valuable experience within a multinational company
IF YOU FIT THE ABOVE MENTIONED REQUIREMENTS, APPLY AND SEND ME A COPY OF YOUR CV !
Simone Mantillaro,Market Researcher,NonStop Pharma
Email: s.mantillaro@nonstop-pharma.it
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.
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert